Tysabri makes Avonex more effective for MS -Elan
Tysabri makes Avonex more effective for MS -Elan
Tue Jul 19, 2005 3:50 AM ET
DUBLIN, July 19 (Reuters) - Shares in Irish drugs firm Elan (ELN.I: Quote, Profile, Research) rose 5.7 percent on Tuesday after releasing data showing its suspended Tysabri drug, developed with U.S. company Biogen Idec (BIIB.O: Quote, Profile, Research), improved the effectiveness of Biogen's Avonex in multiple sclerosis treatment.
"The addition of Tysabri to Avonex resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by Avonex alone," the firms said in a statement.
Data from a two-year study also showed that using Tysabri in conjunction with Avonex led to a 56 percent relative reduction in the rate of clinical relapses.
"The reduction in relapse rate was statistically significant and sustained over the entire two-year study period," the companies noted.
Shares in Elan rose 5.7 percent to 6.35 euros by 0730 GMT in a flat Irish stock market and in line with a rise in the stock in the United States overnight (ELN.N: Quote, Profile, Research).
"These data further illustrate the effectiveness of Tysabri in the treatment of MS," said Ian Hunter, analyst at Goodbody Stockbrokers, in a research note.
Elan's shares plunged 70 percent at the end of February when Biogen and Elan suspended Tysabri sales following reports of a rare and potentially fatal disease of the central nervous system, known as PML, in patients taking the drug.
The companies are conducting a safety review before a decision can be made to bring the drug back to market.
"Our extensive safety evaluation, in collaboration with leading experts and regulatory agencies, is on track and we hope to have findings by the end of the summer," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.
Tuesday, July 19, 2005
Two-Year Sentinel Data Evaluating TYSABRI in Addition to AVONEX Reinforce Efficacy in Multiple Sclerosis
CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Jul 18, 2005 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that SENTINEL, the Phase III TYSABRI(R) (natalizumab) add-on trial with AVONEX(R) (Interferon beta-1a), achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of multiple sclerosis (MS). The addition of TYSABRI to AVONEX resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by AVONEX alone. Data from SENTINEL also demonstrated that the addition of TYSABRI to AVONEX led to a 56 percent relative reduction in the rate of clinical relapses compared to that provided by AVONEX alone. The reduction in relapse rate was statistically significant and sustained over the entire two-year study period.
Other efficacy data from SENTINEL at two years, including MRI measures and immunogenicity, were similar to previously reported one-year results.
Common adverse events included headache, nasopharyngitis, limb pain, depression, flu-like symptoms, diarrhea, insomnia, sinusitis, influenza, nausea, muscle pain, anxiety and cough. The rate of infection was 1.6 per patient-year in both AVONEX plus TYSABRI-treated patients and AVONEX plus placebo-treated patients. Serious infections occurred in 2.9 percent of AVONEX plus placebo-treated patients and 2.7 percent of AVONEX plus TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions which occurred at an incidence of less than 1 percent of patients.
On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. The companies have previously reported three confirmed cases of PML, two of which were fatal. Two of the patients with confirmed PML had received AVONEX plus TYSABRI for over two years as part of the SENTINEL trial. Biogen Idec and Elan's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine the appropriate path forward for TYSABRI.
"These data demonstrate the effect of TYSABRI on disability progression and clinical relapses. We continue to believe in the therapeutic benefit of TYSABRI in MS, a disease with significant unmet medical need," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "Our extensive safety evaluation, in collaboration with leading experts and regulatory agencies, is on track and we hope to have findings by the end of the summer. As always, our primary commitment is to improving the lives of people with MS."
"TYSABRI continues to show benefit in the treatment of immune-mediated diseases," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan. "Patient safety is our top priority. We remain strongly committed to defining TYSABRI's benefit-risk profile and determining the appropriate path forward."
SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. In the trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.
The companies anticipate that two-year data from SENTINEL will be presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Thessaloniki, Greece, which begins September 28, 2005.
About TYSABRI
Biogen Idec and Elan are collaborating equally on the development of TYSABRI in MS, Crohn's disease, and rheumatoid arthritis. On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. Worldwide regulatory agencies are being kept informed of developments related to TYSABRI.
Information about TYSABRI, including the voluntary suspension of marketing and US prescribing information, is available at 1-800-456-2255 and www.TYSABRI.com.
About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company. We are committed to making a difference in the lives of patients and their families by dedicating ourselves to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the potential for TYSABRI and the timing of the presentation of the two-year data from SENTINEL. These statements are based on the companies' current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. There is no assurance, for example, that TYSABRI is not linked to PML, that there are not or will not be more PML cases or other serious adverse events associated with TYSABRI or that we will be able to gain sufficient information to fully understand the risks associated with TYSABRI. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI in any indication. There is also no assurance that all experiences with TYSABRI will be the same or that the potential for TYSABRI will not be affected by unexpected new data or technical issues. For more detailed information on the risks and uncertainties associated with TYSABRI and the companies' drug development and other activities, see the periodic and other reports of Biogen Idec Inc. and Elan Corporation, plc filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Biogen Idec Amy Brockelman, 617 914 6524 Oscar Velastegui, 617 679 2812 or Elan Sarah Datz, 212 407 5740 Emer Reynolds, 353 1 709 4000 800 252 3526
http://www.pharmalive.com/news/index.cfm?articleID=257124&categoryid=48
The Immune Response Corporation Signs a $15 Million Financing Agreement
John N. Bonfiglio, Ph.D., President and CEO of The Immune Response Corporation, said, "We are enthusiastic about entering into this agreement with Cornell Capital. The flexibility and control afforded by this capital structure will enable us to access capital at times when we believe the appropriate value is reflected in our stock price, as development milestones are achieved or when additional liquidity is necessary. The SEDA allows us to make financing decisions that we believe will be in the best interest of the Company and its shareholders."
Under Nasdaq rules, the Company will be required to obtain stockholder approval before drawing down the bulk of the SEDA funding. The Company will promptly seek such stockholder approval.
About The Immune Response Corporation
The Immune Response Corporation (Nasdaq: IMNR) is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS). The Company's HIV products are based on its patented whole-killed virus technology, co-invented by Company founder Dr. Jonas Salk to stimulate HIV immune responses. REMUNE(R), currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax(TM), which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.
Please visit The Immune Response Corporation at www.imnr.com
This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of REMUNE(R), NeuroVax(TM)or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that REMUNE(R), NeuroVax(TM)or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R), NeuroVax(TM)or IR103 in preclinical trials and/or earlier clinical trials. These risks, among others, are set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2004, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.
REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
Source: Business Wire
http://www.rednova.com/news/display/?id=178333&source=r_health
NY Times Op-Ed
July 19, 2005
Punishing Pain
By JOHN TIERNEY
Zephyrhills, Fla.
When I visited Richard Paey here, it quickly became clear that he posed no menace to society in his new home, a high-security Florida state prison near Tampa, where he was serving a 25-year sentence. The fences, topped with razor wire, were more than enough to keep
him from escaping because Mr. Paey relies on a wheelchair to get around.
Mr. Paey, who is 46, suffers from multiple sclerosis and chronic pain from an automobile accident two decades ago. It damaged his spinal cord and left him with sharp pains in his legs that got worse after a botched operation. One night he woke up convinced that
the room was on fire.
"It felt like my legs were in a vat of molten steel," he told me. "I couldn't move them, and they were burning."
His wife, Linda, an optometrist, supported him and their three children as he tried to find an
alternative to opiates. "At first I was mad at him for not being able to get better without the medicines," she said. "But when he's tried every kind of therapy they suggested and he's still curled up in a ball at night crying from pain, what else can he do but take
more medicine?"
The problem was getting the medicine from doctors who are afraid of the federal and local crusades against painkillers. Mr. Paey managed to find a doctor willing to give him some relief, but it was a "vegetative dose," in his wife's words.
"It was enough for him to lay in bed," Mrs. Paey said. "But if he tried to sit through dinner or use the computer or go to the kids' recital, it would set off a crisis, and we'd be in the emergency room. We kept going back for more medicine because he wasn't getting
enough."
As he took more pills, Mr. Paey came under surveillance by police officers who had been
monitoring the prescriptions. Although they found no evidence that he'd sold any of the drugs, they raided his home and arrested him.
What followed was a legal saga pitting Mr. Paey against his longtime doctor (and a former friend of the Paeys), who denied at the trial that he had given
Mr. Paey some of the prescriptions. Mr. Paey maintains that the doctor did approve the disputed
prescriptions, and several pharmacists backed him up at the trial. Mr. Paey was convicted of forging prescriptions.
He was subject to a 25-year minimum penalty because he illegally possessed Percocet and other pills weighing more than 28 grams, enough to classify him as a drug trafficker under Florida's draconian law (which treats even a few dozen pain pills as the equivalent of a
large stash of cocaine).
Scott Andringa, the prosecutor in the case, acknowledged that the 25-year mandatory penalty was harsh, but he said Mr. Paey was to blame for refusing a plea bargain that would have kept him out of jail.
Mr. Paey said he had refused the deal partly out of principle - "I didn't want to plead guilty to
something that I didn't do" - and partly because he feared he'd be in pain the rest of his life because doctors would be afraid to write prescriptions for anyone with a drug conviction.
If you think that sounds paranoid, you haven't talked to other chronic-pain patients who've become victims of the government campaigns against prescription drugs. Whether these efforts have done any good is debatable (and a topic for another column), but the harm is clear to the millions of patients who aren't getting enough medicine for their pain.
Mr. Paey is merely the most outrageous example of the problem as he contemplates spending the rest of his life on a three-inch foam mattress on a steel prison bed. He told me he tried not to do anything to aggravate his condition because going to the emergency
room required an excruciating four-hour trip sitting in a wheelchair with his arms and legs in chains.
The odd thing, he said, is that he's actually getting better medication than he did at the time of his arrest because the State of Florida is now supplying him with a morphine pump, which gives him more pain relief than the pills that triggered so much suspicion. The illogic struck him as utterly normal.
"We've become mad in our pursuit of drug-law violations," he said. "Generations to come will look back and scarcely believe what we've done to sick
people."
E-mail: tierney@nytimes.com
For Further Reading:
http://www.cato.org/pubs/pas/pa545.pdf
Treating Doctors as Drug Dealers: The DEA's War on
Prescription Painkillers by Ronald T. Libby. Cato
Institute, 28 pp., June 2005.
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Multiple Sclerosis Research - Coping with MS - The Ohio State University
Dear potential participant,
My name is Holly M. Chalk, and I am currently a graduate student in the department of Psychology at the Ohio State University. My advisor at OSU is Dr. Don M. Dell. I am conducting a study about coping with multiple sclerosis, from initial diagnosis to subsequent exacerbations.
Ever since I was diagnosed with MS at the age of 21, I have been interested in the emotional and psychological effects of MS. I know from personal experience that coping with the initial diagnosis of MS, as well as coping with subsequent exacerbations and life changes, can be extremely challenging. I hope to explore coping with MS, in order to establish more effective ways of dealing with the uncertainty of this diagnosis.
If you have been diagnosed with MS or provide any care/assistance to an individual with a diagnosis of MS, I invite you to participate in this study. Your participation would entail filling out various questionnaires online. The time you might spend on this study would be between 30-40 minutes. Your participation will allow us to gain more information about successful ways to cope with multiple sclerosis.
I am deeply invested in the fight to improve the quality of life for individuals who have been diagnosed with MS. If you or someone close to you suffers from MS, Im sure that you share my interest in finding ways to live a happy life with MS. I would truly appreciate your participation in this study. The results of this study will be posted on http://msresearch.dyndns.org when data collection and analysis are completed.
Please understand that participation is voluntary and you may withdraw at any time by closing your web browser. If you decide that you would like your responses deleted from the study, you will have the opportunity to do so. During the survey, no identifying information will be requested from you, and the information you provide will be kept confidential by researchers. There is a possibility, although remote, that your IP address could be identified or that you responses could be intercepted during transmission. However, your numerical responses will not be linked to questions, and therefore, would not be meaningful.
In order to participate in my study, please follow the link below. Please let me know if you have any questions or concerns. Thank you for your time and commitment to MS research.
I would like to participate in this survey.
Copyright, 2005. The Ohio State University.
This page is maintained by:
Holly McCartney Chalk, M.A.
Counseling Psychology Doctoral Candidate
The Ohio State University
chalk.12@osu.edu
http://msresearch.dyndns.org/
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Monday, July 18, 2005
Blocking the effects of interleukin-1 will prevent brain damage, new research
http://www.medicalnewstoday.com/medicalnews.php?newsid=27545
Doctors know that the body's natural response to injury - inflammation - can do more harm than good when it comes to the brain.
But new research from Steven Levison, Ph.D., associate professor of neuroscience and anatomy, Penn State College of Medicine, explains the cellular and molecular reasons why this is true. Furthermore, his research provides important information that could lead to new drugs to prevent brain cell death after injury or as a consequence of neurodegenerative diseases like Alzheimer's.
Levison's study on mice, published in the July 15, 2002, print edition of Journal of Neuroscience, not only describes an important mechanism by which the body reacts to brain injury, but goes farther to show why inhibiting the effects of interleukin-1 - a protein immune cells release in response to injury - will stop additional brain tissue damage. The article will be released on-line on July 16, 2002.
"The study provides strong rationale for testing IL-1 receptor blocking reagents as treatments for traumatic brain injury and stroke, and even neurodegenerative diseases like multiple sclerosis and Alzheimer's disease," Levison said.
In both mice and humans, IL-1 is a vital component of the injury response. When IL-1 is released into a tissue, it activates scavenger cells known as macrophages to move into the injury site and cause inflammation. Macrophages release substances that kill bacteria and viruses, and they ingest dead cells. They also release IL-1, which signals more macrophages to invade the damaged tissue.
"The macrophage reaction is a good one in regenerating tissues, but in a non-regenerating tissue like the brain, it can be devastating," Levison said.
When macrophages release IL-1 and attract more of the scavenger cells to the brain, they become exited and overactive, causing harm to other cells nearby. This adds to the damage caused by the initial injury and destroys more healthy neurons. Therefore, instead of helping, the release of IL-1 and the subsequent activation of brain macrophages may have additional severe and irreversible consequences for brain function.
To determine whether inflammation would be decreased when IL-1 stimulation is blocked, Levison and his colleagues evaluated brain injury in mice that lacked the capacity to respond to IL-1. In their study of these so-called IL-1 receptor null mice, Levison and his colleagues found that fewer macrophages were attracted to the brain, and that the brain's macrophages, know as microglia, were not as excited and did not produce substances that would harm healthy brain cells.
"These data suggest that cell preservation is achieved by stopping macrophage, or microglial, activation," Levison said. "In addition, the research shows that the initial burst of IL-1 causes more IL-1 to be released, which amplifies the injury response. This causes a runaway inflammation in the brain where you don't want it. It's as David Bowie would put it, 'like putting out the fire with gasoline.' This study helps us understand why inflammation in the brain is not good and specifically why IL-1 is not good for the brain."
Previous studies by a variety of investigators have shown that IL-1 is elevated after traumatic brain injury, multiple sclerosis, Alzheimer's Disease and Downs Syndrome and that mice with reduced IL-1 are significantly protected from ischemic injury - brain damage caused by a lack of oxygen reaching the brain. Other research showed that administering a substance that inhibits IL-1 reduced neuronal death after ischemia.
By establishing the cellular and molecular components of the Central Nervous System injury response, Levison's work reveals why inhibiting IL-1 will protect brain cells from injury and disease. Additionally, this research could lead to new drug therapies to preserve brain tissue in people who've suffered a brain injury or stroke, or have a neurodegenerative disease.
Levison's group is currently using these mice to test his prediction that there will be less damage caused by stroke. In addition to stroke studies, Levison plans to see whether these mice will be less vulnerable to multiple sclerosis-like diseases.
This study was funded by a grant from the National Multiple Sclerosis Society. IL-1 null mice were provided by Immunex, a biopharmaceutical company based in Seattle, USA
Valerie Gliem
vgliem@psu.edu
717-531-8606
Penn State
http://www.psu.edu
Friday, July 15, 2005
Cell Transplants Protect Brain Tissues By Fighting Immune Attack In Mice With MS-Like Disease
http://www.medicalnewstoday.com/medicalnews.php?newsid=27419#
Researchers at the San Raffaele Hospital (Milan, Italy) published unexpected results of studies in which immature nerve cells (adult mouse neural stem cells) injected into the blood of mice with MS-like disease were able to suppress the immune attacks that damage the brain and spinal cord tissues. The study, funded in part by the National MS Society, is being reported by Drs. Stefano Pluchino, Gianvito Martino and colleagues in the July 14, 2005 issue of Nature. These surprising findings, if confirmed, suggest that neural stem cells that reside in the adult brain may not only serve as replacement cells for tissue repair, but in some circumstances may also protect the brain from inflammation. Further research is needed to confirm these results and to address multiple issues involved in translating such experiments into finding ways to fight the immune attack and protect and repair brain tissues in people with MS.
Background: In recent years, scientists have been exploring ways to repair the damage of brain and spinal cord tissues during the course of the immune attack in MS. Evidence suggests that the body successfully repairs some myelin damaged in MS, but not enough to keep up with its loss. Research has shown that adult brains contain stem cells - also known as precursors or progenitors - that might serve as replacement cells. It has been hoped that, given the right signals, these may be stimulated to grow into viable new tissue. The search for these signals is an active area of research. Another possibility being explored is cell transplantation.
Studies involving transplantation of immature myelin-making cells (oligodendrocyte precursors) have been to some degrees successful in rodent models, triggering recovery of function and restoring nerve conduction. However, such repair has only been successful in isolated areas of the brain, whereas MS and MS-like diseases in animal models involve lesions scattered throughout the brain and spinal cord. Finding a way to introduce potential replacement cells that can migrate throughout the central nervous system and home in on damaged areas has presented a significant hurdle in this field.
The San Raffaele Hospital team and others have been investigating transplantation of neural stem cells, which have the potential to develop into various types of brain cells - including nerve cells and myelin-making cells - and which appear capable of expanding their numbers extensively, and moving to distant sites of injury within the brain. In 2003, they reported that neural stem cells transplanted into mice with an MS-like disease were able to migrate to multiple areas of myelin and nerve fiber damage in mice with an MS-like disease, repair this damage, and restore clinical function. (Nature 2003;422:688-694). In the current study, the team attempted to define the mechanisms responsible for the migration of these cells into the brain and to sites of injury. This study was funded in part by the National MS Society (USA), the Myelin Project, the Italian MS Foundation and the Italian Minister of Health.
The Study: Dr. Pluchino and colleagues injected neural stem cells, taken from the brains of adult mice, into the blood of mice with a relapsing-remitting form of EAE, an MS-like disease. Relapsing-remitting disease involves clearly defined flare-ups followed by partial or complete remissions. Some mice were injected at the onset of disease, and others at the onset of the first relapse.
Mice in which neural stem cells were injected at disease onset started to recover between 30 and 60 days, and experienced a twofold reduction in relapses compared with untreated mice. Mice injected at the first relapse started to recover later, but showed a threefold reduction of the relapse rate between 60 and 90 days, compared with untreated mice. Both groups showed a significant reduction in the extent of myelin damage and nerve fiber loss compared to untreated mice.
The team then explored the mechanism by which the neural stem cells entered the brain from the bloodstream. They reported that a protein on their surface called VLA-4, which is also found on immune cells and allows them to cross from the blood into the brain, facilitated their movement into the brain. In addition, the investigators reported finding a wide range of immune proteins to be active on the transplanted neural stem cells; these proteins serve as “docking sites” to receive signals from immune cells active in the attack. Furthermore, they reported that a portion of the transplanted cells remained in an immature state and accumulated in the brain around blood vessels (perivascular areas) where immune cells enter the brain during active disease. These transplanted cells showed signs of being able to turn off activated immune cells and reduce inflammation, thus protecting brain tissues from immune-mediated damage.
Conclusion: These exciting and unexpected findings from a respected group of investigators, if confirmed, suggest that transplanted neural stem cells may serve not only as replacement cells for tissue repair, but in some circumstances may also protect the brain from inflammation. Further research is needed to confirm these results and to address multiple issues involved in translating such experiments into finding ways to fight the immune attack and protect and repair brain tissues in people with MS.
New Findings on MS Drug Effectiveness Unveiled
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| by John C. Martin | Article Date: 07-14-05 |
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Doctors released new information in June on the effectiveness of a currently available medication for multiple sclerosis.1 The drug is known as Copaxone, also known by its generic name, glatiramer acetate injection.
Copaxone is indicated to reduce the number of relapses in people with relapsing MS. While it's not known exactly how the drug works, it's believed it stimulates pro-inflammatory immune cells to switch to anti-inflammatory cells. The immune cells then encounter damage in the central nervous system and apparently reduce inflammation at the site of the lesion.2
Another Perspective
Omar Khan, MD, an associate professor of Neurology at Wayne State University, led a small study of 18 people with relapsing-remitting multiple sclerosis to more closely determine how the medication helped people with MS recover.
Each patient underwent an imaging procedure known as magnetic resonance spectroscopy (MRS). This is a type of magnetic resonance imaging; it provides chemical rather than anatomical information. The chemicals can give radiologists clues about how MS may influence chemical processes in the brain.3
MRS imaging was used in this study to prove that Copaxone exerts its effect inside the brain and spinal cord, Khan told Priority Healthcare, in an e-mail interview.
One of the chemicals measured in the study is known as n-acetylaspartate (en-uh-see-till-uh-SPAR-tate), or NAA, an indicator that neurons in the brain are functioning normally. An increase in levels of NAA in the brain relative to another chemical known as creatinine (kree-AA-tuh-neen) can serve as an indicator that injured nerve cells or neurons in the brain are recovering. (The relationship between NAA and creatinine on MRS readings is written as NAA/Cr ratios.)
In fact, this was the first study of Copaxone to use this diagnostic measurement as an indicator of the drug's effectiveness, Khan explained.
In MS, it is nerve cells and the fatty sheath known as myelin that protects them that are the key targets in the disease process. For as yet unknown reasons, the body's immune system mistakenly attacks myelin and nerve cells, damaging or destroying them, and thus, causing the symptoms that crop up in MS.4
'Improved Recovery'
"Copaxone treatment led to increased NAA/Cr ratios, suggesting improved cerebral axonal recovery in relapsing-remitting MS patients, indicating a potential benefit on the pathways of electrical conduction in the brain," explained Khan, who is also Director of Experimental Therapeutics and Clinical Research at Wayne State University's Multiple Sclerosis Center.
Axons are the connections in the brain by which nerve cells communicate with each other. They can also be damaged when MS strikes. Preventing or minimizing damage to nerve cells is critical in reducing long-term disability in MS, the research team pointed out.
Patient Follow-Up
In their open-label study (meaning both clinical staff and patients knew the name of the medication being tested), Khan and his colleagues followed most of the patients for a three-year period while they were taking the drug. In addition, four patients in an untreated group were followed for the first two years, and half of those began therapy with Copaxone in the study's third year. Each patient underwent both MRI and MRS exams before therapy began and then yearly afterwards. Every six months, the investigators also measured each patient's level of disability to determine if they had relapsed at any time. The results, presented at a neurology conference in Europe, involved new data from the ongoing study.
"NAA/Cr ratio remained stable during the third year, and significantly improved compared to baseline and the untreated group," Khan's team reported. The patients in the non-treated group who later began therapy also showed improvements in the ratio of these two chemicals compared to their levels at the start of the study. Two patients who remained untreated had continued declines in their NAA/Cr ratio, the investigators found.
"These MRS data suggest an action of Copaxone in the central nervous system, resulting in a sustained beneficial effect on cerebral axonal injury," said Khan. "No other approved treatment for relapsing-remitting MS has been shown to have a beneficial effect on MRS scans over a three-year period."
Benefits of Early Therapy
In a similar, but unrelated study,5 doctors in Italy compared the effectiveness of Copaxone begun immediately versus its effectiveness when treatment was delayed. The researchers enrolled 142 patients in an open-label extension trial of an earlier MRI study, and assigned them to two groups. One group received Copaxone at the start of the extension study and the second group received the medication after taking a placebo for the first 9 months, and then switched to the drug.
The researchers found that a greater number of patients in the group taking Copaxone from the beginning did not reach significant disability—defined in the study as needing intermittent or constant assistance like a cane, crutch or brace—compared to patients who were given the drug on a delayed basis.
The results suggest that starting Copaxone treatment early for people with active relapsing MS may have a positive impact on long-term disease evolution by slowing the progression to serious disability, the investigators concluded.
1. Khan O, Shen Y, Hu J et al. Sustained effect of glatiramer acetate on cerebral axonal recovery in relapsing-remitting MS: results after three years of serial brain magnetic resonance spectroscopy examination. 15th Meeting of the European Neurological Society. 2004 Jun 18-22. Vienna, Austria.
2. Teva Pharmaceutical Industries. About Copaxone. Available at: http://www.mswatch.com/therapy/section.aspx?SectionId=789eabf5-3a07-4dff-a7ee-0d4ad1381a6d. Accessed July 8, 2005.
3. University of Arkansas Medical Sciences. Department of Radiology. College of Medicine. Magnetic Resonance Spectroscopy (MRS): Introduction. Available at: http://www.uams.edu/radiology/info/research/mrs/. Accessed July 8, 2005.
4. National Multiple Sclerosis Society. What is Multiple Sclerosis? Available at: http://www.nationalmssociety.org/What%20is%20MS.asp. Accessed July 8, 2005.
5. Rovaris M, Comi G, Rocca M et al. Long-term follow-up of patients treated with glatiramer acetate: a multi-centre, multi-national extension of the European/Canadian double-blind, placebo-controlled, MRI-monitored trial. 15th Meeting of the European Neurological Society. 2004 Jun 18-22. Vienna, Austria.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
Multiple Sclerosis
Multiple Sclerosis
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Discovery of T-cell 'traffic control' boosts new drug promise
The traffic control system -- composed of a fat-like compound called S1P and its receptor on T cells -- usually prevents T cells from launching harmful reactions. But when the S1P traffic cop reacts incorrectly, T cells can swamp healthy tissue. The new research explains how a promising experimental drug treats the autoimmune disease multiple sclerosis by blocking excess S1P action. The research also shows the promise of similar strategies to prevent rejection of transplanted organs and tissues without compromising essential immune defenses.
The emerging view brings together research findings on S1P's effect on both the immune system and the blood-circulating vascular system, showing how the two systems interact to regulate T cell circulation and prevent a constant and potentially dangerous release of T cells, or lymphocytes.
The research is presented this month in a special issue of Nature Reviews Immunology. Authors are Edward Goetzl, MD, at UCSF and Hugh Rosen, MD, PhD, at the Scripps Research Institute, scientists who have pioneered the new understanding. Goetzl is the Robert L. Kroc Professor of Medicine and Immunology at UCSF. Rosen is a professor of immunology at Scripps.
Goetzl and Rosen participated in the discovery of S1P's role in T cell trafficking. Goetzl has also shown that S1P regulates T cell trafficking by occupying a receptor on the T cell surface that suppresses the cells' normal response to a "forward march" signal.
T cells respond by chemotaxis -- moving from areas of lower to higher concentration of a signaling molecule known as a chemokine. Studies by the two scientists have shown that S1P and its T cell receptors block this signaling. They slow the flood of T cells "called into" lymph nodes by chemokines.
The scientists made a second discovery about T cell movement: S1P, like chemokines, can also act as a chemotactic attractant to T cells. Once T cells enter lymph nodes -- the sites where they encounter antigens for microbes and other infectious agents -- they sense S1P in the outflowing blood and so migrate into the blood and onto tissues where they are needed to fight infection.
In a key experiment, Goetzl's and Rosen's labs showed that by chemically displacing S1P, its natural braking effect is released, stimulating T cell traffic into lymph nodes. Because this also blocks S1P's chemotactic influence, migration of T cells out of the lymph nodes is greatly reduced. T cells are essentially sequestered in the nodes. Such an effect would prevent T cells from swamping newly transplanted organs or launching a harmful autoimmune reaction, the scientists suggest in the paper.
They think this mechanism underlies the promising clinical trial results of a new drug against multiple sclerosis (MS) recently reported by other researchers. That study showed that the experimental drug, FTY720, significantly reduced the destructive autoimmune process in patients with MS, a debilitating disease in which the body's T cells attack the myelin coating of nerve cells and disrupt their function. Neither Goetzl nor Rosen is involved in the on-going clinical trials of the new drugs and neither has financial ties to the companies that manufacture them.
Controlling this process with drugs offers "enormous potential" against devastating immune reactions, Goetzl says.
"Transplanting organs or even cells, such as insulin-producing Beta cells, into a patient triggers immune reactions that reject the transplant, but a drug such as FTY720 controls S1P function and slows the rush of T cells to the transplantation site without blocking normal immune response against bacteria and other infectious agents," he says. Similarly, such a drug should slow the autoimmune response that occurs in MS, a hypothesis recently confirmed in phase 2 clinical trials, he says.
Such drugs do not interfere with essential protective immune function since bacterial proteins that normally trigger immune defense do so when they enter lymph nodes -- "where the T cells are essentially trapped by the drug for a few days, but still are working fine and allowing new antibody formation," he explains.
Treatment using this drug strategy does not come without risks, Goetzl cautions. Current drugs that affect one type of S1P receptor affect all others as well, and some of these control heart rate and muscle development. In clinical trials of some of these kinds of drugs, a number of patients have tired easily, experienced lower blood flow and a tendency for airways to constrict as muscle walls develop abnormally, Goetzl says.
"Fully exploiting this approach for treatment of autoimmune diseases and transplant rejection will depend on developing new drugs that block only the immune type of S1P receptor," he adds. "But early studies by a number of researchers are quite promising."
Progress will also come from finding "uniquely effective combinations of these agents with other immunosuppressive drugs," he says.
In animal studies and clinical research with patients over more than a decade, scientists have come to understand that millions of T cells and B cells are "called" into lymph nodes by other immune molecules called chemokines.
"But we began to wonder why T cells don't always swarm into lymph nodes and flood on into blood vessels that lead to all parts of the body," Goetzl says. "We asked ourselves, 'What is the brake?'"
In research with mice that have T cells that lack S1P receptors or have over-expressed receptors, the Goetzl and Rosen labs and others determined that T cells have on their surfaces what are known as G protein-coupled receptors, which when occupied by chemokines -- their natural binding partners -- prompt the T cells to rush into lymph nodes. But S1P, they found, can act through its own G-coupled receptors to prevent chemokines from triggering T cell movement. In ways not yet fully understood, this process is reversible, providing the body with a crucial control over when and how much of the potent T cell soldiers to release into the blood stream.
Research support for both Goetzl and Rosen comes from the National Institutes of Health.
NOTE: S1P is an abbreviation for Sphingosine1-phosphate, one of a family of fat-like molecules that affect proliferation and diverse functions of many cell types.
http://www.eurekalert.org/pub_releases/2005-07/uoc--dot071405.php
Thursday, July 14, 2005
Headache
Headache
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Clinical Trials: Multiple Sclerosis
Clinical Trials: Multiple Sclerosis
http://tinyurl.com/8m4dd
Alabama
Cullman; North Central Neurology
Are you a new patient to Copaxone®?Arizona
Phoenix; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Phoenix; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Phoenix; Barrow Neurological Clinics
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Phoenix; 21st Century Neurology
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetatePhoenix; Barrow Neurology Clinics at St.Joseph Hospital & Medical Center
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetatePhoenix; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisSun City; Dedicated Clinical Research
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Tucson; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Arkansas
Little Rock; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Little Rock; Clinical Trials, Inc.
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Little Rock; Clinical Trials, Inc
Multiple Sclerosis (Relapsing-Remitting or Secondary-Progressive)California
Berkeley; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisFountain Valley; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Fullerton; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Irvine; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Irvine; NervePro Research
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.La Jolla; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.La Jolla; Center for Neurologic Study
Do you have a hard time controlling your emotions?La Jolla; Coordinated Clinical Research (La Jolla, CA)
Do you have relapsing-remitting multiple sclerosis?Laguna Hills; Neurophysiologic Laboratory
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Sacramento; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Sacramento; Sutter Institute for Medical Research
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateSacramento; UCDMC Dept of Neurology
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Colorado
Boulder; Alpine Clinical Research
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Boulder; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisDenver; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Florida
Bradenton; Bradenton Neurology, Inc.
Bradenton Neurology, Inc. is participating in a nationwide research study for individuals who have been diagnosed with Multiple Sclerosis.Maitland; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Miami; University of Miami - MS Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Miami; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Miami; Jackson Memorial Hospital
Volunteers Needed For Research StudyOrlando; MS Comprehensive Care Center of Central Florida
Are you a new patient to Copaxone®?Plantation; Neurology Clinical Research, Inc.
Do you or a loved one have Multiple Sclerosis?Plantation; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Tallahassee; AMO Corporation
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Tampa; Axiom Clinical Research of Florida
Beta Interferon Dose-Frequency Trial in Patients with Relapsing-Remitting MSGeorgia
Atlanta; MS Center of Atlanta
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Atlanta; Shepherd Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Atlanta; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Augusta; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Augusta; Medical College of Georgia
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateColumbus; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Decatur; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Idaho
Boise; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Illinois
Chicago; University of Chicago
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Northbrook; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Northbrook; Consultants in Neurology, Ltd.
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Northbrook; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisIndiana
Elkhart; Elkhart Clinic, LLC
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateFort Wayne; Fort Wayne Neurological Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Indianapolis; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Indianapolis; Indiana Neuroscience Institute
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Iowa
Des Moines; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Kansas
Kansas City; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Kansas City; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Kansas City; University of Kansas Medical Center Research Institute
DCR# 2711, a study for subjects with relapsing multiple sclerosis to evaluate the safety and tolerability of the study drug and the effect of the study drug on lesions as seen on a Magnetic Resonance Imaging (MRI) scan.Kansas City; University of Kansas Medical Center Research Institute
A study to establish the safety and effectiveness of Interferon Beta- 1b and Interferon-1a combination injections (either under the skin or into the muscle) in subjects with relapsing-remitting multiple sclerosis (MS) who were previously treated with Beta Interferon-1a.Lenexa; MidAmerica Neuroscience Institute
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Kentucky
Lexington; University of Kentucky Chandler Medical Center
Volunteers Needed for Multiple Sclerosis Research StudyLexington; University of Kentucky Chandler Medical Center
Volunteers Needed for Multiple Sclerosis Research Study.Louisville; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Louisiana
Baton Rouge; The Baton Rouge Clinic, AMC
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateMaryland
Baltimore; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Massachusetts
New Bedford; Bayside Neurology
Are you a new patient to Copaxone ®?Springfield; Springfield Neurology Associates, LLC.
Do you have Multiple Sclerosis?Michigan
Detroit; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Detroit; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Detroit; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Detroit; 8D University Health Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Farmington Hills; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Grand Rapids; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisKalamazoo; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Saginaw; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Traverse City; Northern Michigan Neurology
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Minnesota
Golden Valley; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Minneapolis; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Minneapolis; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Minneapolis; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Minneapolis; University of Minnesota/Clinical Neuroscience Research Unit (CNRU)
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateMissouri
Lee's Summit; Kansas City Clinical Neurology Associates
Are you a new patient to Copaxone®?St. Louis; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.St. Louis; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.St. Louis; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).St. Louis; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).St. Louis; Radiant Research
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateSt. Louis; Washington University MS Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Montana
Billings; Deaconess Billings Clinic Research Center
Multiple SclerosisGreat Falls; Advanced Neurology Specialists
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateNevada
Henderson; Nevada Neurological Consultants, Ltd.
Clinical trial of an investigational medication for patients with relapsing-remitting multiple sclerosis ("RRMS").Henderson; Nevada Neurological Consultants, Ltd.
Participants needed for a research study in Multiple SclerosisLas Vegas; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.New Hampshire
LeBanon; Ayres and Associates Clinical Trials
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.New Jersey
Edison; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Morristown; Neuro Science Center of Northern NJ, PA
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateNewark; New Jersey Medical School, Multiple Sclerosis Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Ridgewood; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.New Mexico
Albuquerque; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).New York
Albany; Upstate Clinical Research, LLC
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Albany; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisAmherst; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Amherst; Dent Neurological Institute
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateBrooklyn; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Brooklyn; Multiple Sclerosis Care Center
Are you a new patient to Copaxone®?Mineola; Winthrop South Nassau University Health System Clinical Trials Network
Multiple Sclerosis is a chronic disease of the central nervous system that affects approximately 350,000-400,000 people in the United States. The purpose of this study is to determine whether the combination of interferon beta 1-a (Avonex) and glatiramer acetate (Copaxone) is an effective therapy for Relapsing-Remitting form of Multiple Sclerosis.Mineola; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisMineola; Winthrop South Nassau University Health System Clinical Trials Network
Relapsing-remitting multiple sclerosis for patients previously treated with Avonex®Mineola; Winthrop South Nassau University Health System Clinical Trials Network
Relapsing-remitting MS studyNew York; Mount Sinai Medical Center
A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Rituximab in Adults with Primary Progressive Multiple Sclerosis PROTOCOL: U2786gNew York; Mount Sinai Medical Center
Open-Label Study of the Safety and Effectiveness of Combination Therapy with Mitoxantrone and interferon B1a or glatiramer acetate.New York; Mount Sinai Medical Center
5 year study to evaluate use of Novantrone(mitoxantrone) infusions in Multiple Sclerosis (MS) patientsNew York; Mount Sinai Medical Center
OMEGA-Oral Megadose Corticosteroid Therapy of Acute Exacerbations in Multiple SclerosisNew York; Mount Sinai Medical Center
IGIV-C (Intravenous Immunoglobulin- Chromatogrpahy) in Relapsing Remitting Multiple SclerosisNew York; Mount Sinai Medical Center
A 20 Week Study to Evaluate the Safety and Tolerability of Fampridine-SR in Subjects with Multiple SclerosisNew York; Mount Sinai Medical Center
A Phase II study to look at a drug called BMS 188667 given to patients with Relapsing Remitting MS.Plainview; Island Neurological Associates, P.C.
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateRochester; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Stony Brook; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Stony Brook; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).North Carolina
Charlotte; Carolinas Medical Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Charlotte; Carolinas MS Center
Are you a new patient to Copaxone®?Winston-Salem; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Winston-Salem; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Ohio
Akron; Neurology and Neuroscience Associates
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateBellevue; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Bellevue; Advanced Neurological Associates
Are you a new patient to Copaxone®?Canton; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Canton; Neurocare Center Inc.
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateColumbus; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Columbus; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Columbus; The Ohio State University
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Columbus; Capital Neurology Services
Are you a new patient to Copaxone®?Dayton; Neurology Specialist, Inc.
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Uniontown; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Uniontown; Oak Clinic for Multiple Sclerosis
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateWilmington; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Oklahoma
Oklahoma; MS Center of Oklahoma
Are you a new patient to Copaxone®?Pennsylvania
Danville; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Danville; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Danville; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Norristown; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Tennessee
Clarksville; Alpha Clinical Research, LLC
Multiple Sclerosis (MS)Nashville; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Nashville; Teva Neuroscience
A Multinational, Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment (Copaxone®) in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting with a Clinically Isolated Syndrome (CIS).Nashville; Advanced Neurosciences Institute
Are you a new patient to Copaxone®?Texas
Dallas; Neurology Specialists of Dallas, P.A.
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateDallas; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisGalveston; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Houstin; University of Texas, Houston Health Science Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Houston; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Rochester; Univeristy of Rochester
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateSan Antonio; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.San Antonio; Integra Clinical Research, LLC
Are you a new patient to Copaxone®?San Antonio; Integra Clinical Research, LLC
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateWichita Falls; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Vermont
Bennington; Neurological Research Center
A research study for patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis.Virginia
Charlottesville; University of Virginia
Men and Women Ages 18 - 55 Needed for Multiple Sclerosis StudyCharlottesville; University of Virginia
Men and women 18 - 65 with Primary Progressive MS wanted for research studyCharlottesville; University of Virginia
Effect of Estrogen Replacement Therapy for Postmenopausal Women with MSFairfax; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Fairfax; Neurology Center of Fairfax
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateVirginia Beach; Virginia Beach Neurology
Are you a new patient to Copaxone®?Washington
Seattle; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Spokane; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Spokane; Rockwood Clinic, PS
Are you a new patient to Copaxone®?Spokane; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisSpokane; Rockwood Clinic
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateTacoma; Teva Neuroscience
A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to that of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients.Tacoma; Neurology & Neurosurgery Assoc. of Tacoma, PLLC
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer AcetateWenatchee; Research Site
A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center, Dose-Ranging, Parallel-Design Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple SclerosisWest Virginia
Charleston; Capital Neurology
ASSERT: Assessment Study of Steroid Effect In Relapsing Multiple Sclerosis Subjects Treated with Glatiramer Acetatehttp://www.centerwatch.com/cgi-bin/cl.pl?p=patient/studies/cat102.html&h=msifhead.txt&f=msiffoot.txt
![[*]](http://www.centerwatch.com/patient/images/newtiny.gif)
Injections could one day treat neurological diseases, mice study concludes
http://www.msnbc.msn.com/id/8564278/
Updated: 1:47 p.m. ET July 13, 2005
MILAN - Stem cells may protect the brain and nervous system against damage from tumors and conditions such as multiple sclerosis, researchers at Milan’s San Raffaele Scientific Institute found.
Experiments with mice with a disease similar to multiple sclerosis showed that stem cells injected into the blood stream migrated to inflamed areas in the brain and spinal cord, killing inflammatory cells, the researchers said.
This suggests that a single injection of stem cells could be used to treat many different areas of damage in the body, reducing the clinical signs of the disease.
“There is a therapeutic potential in this discovery, but it’s still too early to talk about a cure for humans,” head of research Gianvito Martino told a news conference.
Mice treated with stem cells at the onset of the disease started to recover between one or two months, the team reported.
Stem cells are primitive cells that can transform themselves into many specialized forms, such as blood cells. Their potential of regenerating organs or tissue has given hope to sufferers from nervous diseases such as multiple sclerosis.
The researchers said the stem cells could also potentially be used as a natural anti-inflammatory drug to treat damage by diseases such as stroke, brain tumors, and spinal cord injuries.
“With this discovery, we are moving closer to a targeted use of stem cell therapy without side effects,” researcher Stefano Pluchino said.
“The interesting thing is that adult stem cells grow in vitro without becoming specialized, they are injected and they find the damaged organ by themselves and decide autonomously how to treat it.”
The results of the study will be published in Nature magazine this week.
http://www.msnbc.msn.com/id/8564278/
Tuesday, July 12, 2005
Experimental Therapy May Lead to Better Multiple Sclerosis Treatment
A new therapy effectively treats a disease similar to multiple sclerosis (MS) in monkeys, and the approach could soon be tested against MS and other autoimmune diseases in humans. The therapy's promising results, reported by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), will be published in the February 1 issue of the Journal of Immunology.
"Current treatments for MS broadly suppress the immune system and can cause toxic side effects," says senior study author Michael Lenardo, M.D., of NIAID's Laboratory of Immunology. "This treatment, called antigen-specific immunotherapy, specifically targets the immune system's T cells that cause the disease. Presumably, it would not lead to such side effects."
Autoimmune diseases such as rheumatoid arthritis, type 1 diabetes and MS affect approximately 5 percent of the U.S. population. Directly and indirectly, they cost the U.S. economy more than $100 billion per year. "Immune-mediated diseases are a major cornerstone of the NIAID research effort," says Anthony S. Fauci, M.D., director of NIAID. "Efforts such as Dr. Lenardo's hold great promise for developing new treatments for individuals with autoimmune diseases."
MS is a paralyzing disease that affects nerves in the brain and spinal cord, disturbing speech, vision and movement. MS primarily strikes young adults, most often women who live in northern latitudes. The disease is caused by a malfunction in the immune system: certain white blood cells called T cells mistakenly attack myelin sheaths, protective coverings that surround the signal-carrying fibers of nerve cells.
Antigen-specific immunotherapy is based on a discovery by Dr. Lenardo and his colleagues that T cells exposed to small amounts of the proteins making up the myelin sheaths are stimulated to attack the sheaths. But T cells exposed to large amounts of the same proteins will undergo a pre-programmed "self-destruct" sequence. (In fact, T cells exposed to large amounts of any antigen -- a substance that provokes them to attack -- will self-destruct.) Therefore, introducing large amounts of myelin proteins into the body should remove the problematic T cells and halt the disease, Dr. Lenardo explains.
"The therapy is counter-intuitive; one might think it would be like pouring gasoline on a fire," Dr. Lenardo says. But the self-destruct sequence actually protects the body from having too many active T cells, which can themselves be toxic. "Like any potent weapon, you want to control how much is deployed," Dr. Lenardo explains. "The immune system doesn't let your T cells grow uncontrolled and kill you. In this case, adding more antigen smothers the fire."
Dr. Lenardo and his colleagues first injected nine male marmoset monkeys with just enough myelin proteins to stimulate their T cells to attack myelin sheaths, inducing a disease very similar to MS in humans. Three monkeys then received additional large doses of myelin proteins, three received moderate doses, and three received nothing. The monkeys were observed for 105 days. All three of the untreated monkeys showed clinical symptoms of the disease. In contrast, none of the monkeys in the large-dose group showed symptoms. In the moderate-dose group, two of the three showed symptoms, but those symptoms were significantly delayed.
Magnetic resonance images of the animals' brains revealed severe damage to the myelin sheaths in two of the untreated monkeys and one of the moderate-dose monkeys. Minor damage did occur in the large-dose group, indicating the disease process had not been completely thwarted although it had been greatly suppressed. The treatment appeared to cause no adverse side effects. Researchers at the National Institute of Neurological Disorders and Stroke assisted with the experiment.
Dr. Lenardo and his colleagues are investigating how the therapy works against other autoimmune diseases in laboratory mice. One such disease under investigation is myasthenia gravis, a paralyzing condition affecting children that is caused when the immune system mistakenly attacks the receptors on muscle cells that receive nerve impulses.
NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, tuberculosis, malaria, autoimmune disorders, asthma and allergies.
Immune System Series
http://www.immunecentral.com/immune-system/iss31.cfm
Scientists have long sought the hematopoietic stem cell, the precursor cell that continuously replenishes the body's entire panoply of blood cells, both red and white. Stem cells represent a small portion of all bone marrow cells (perhaps one in 2,000), and they are even rarer in the bloodstream. In the mouse, implanting just a few purified stem cells can completely restore an immune system that has been experimentally destroyed.
Although the human stem cell has yet to be isolated and purified, scientists have discovered that progenitor cells capable of giving rise to an array of blood cells (if not of actually reproducing themselves) carry the cell surface marker CD34. These cells can be sorted out from marrow and blood with monoclonal antibodies that recognize CD34. In experimental programs, CD34 cells are being tested as long-lived vehicles for gene therapy and as an alternative to bone marrow transplants.
Immune System and the Nervous System
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http://www.immunecentral.com/immune-system/iss27.cfm
Monday, July 11, 2005
Why good cells go bad in progression of MS
tom_rickey@urmc.rochester.edu
585-275-7954
University of Rochester Medical Center
Why good cells go bad in progression of MS
Scientists have pinpointed a chemical messenger that frees some white blood cells from the body's normal constraints, allowing the cells to act like renegades that could damage nerves in the central nervous system. The work, to be published in the July 15 issue of the Journal of Immunology and just published on-line, helps explain one of the fundamental mysteries of multiple sclerosis (MS).The scientists discovered that a chemical messenger found at high levels in MS patients allows some immune cells known as T- effector cells to evade normal regulation. Instead, the cells bypass their usual gatekeepers and could become active in the body's tissues, including the brain and spinal cord. Scientists believe that during MS, renegade T-effector cells damage the myelin coating that covers nerve cells, causing the disease's symptoms. While another subset of white blood cells called T-regulatory cells normally control the activation of T-effector cells, investigators found that the chemical messenger interleukin-12 or IL12 allows some cells to sidestep that regulation and run amok.
"Normally effector T cells are under strict control as they circulate through the blood stream in order to prevent unnecessary inflammation that could be harmful to otherwise healthy tissues," says Benjamin Segal, M.D., the neurologist who led the University of Rochester study. "However, occasionally they escape the body's suppression system. We're learning how they do that."
In the 1990s, while working in the laboratory of Ethan Shevach, M.D., at the National Institute of Allergy and Infectious Diseases, Segal was one of the first scientists to show that IL12 could be important in autoimmune diseases like MS. He showed that the molecule empowers CD4+ T cells to enter the central nervous system, where they don't belong, and attack myelin. He has also shown that mice without the IL12 gene are completely protected against an MS-like disease, and that ordinary mice can be protected from developing MS-like symptoms if their IL12 is knocked out. In contrast, exposure of normally harmless T-effector cells to IL-12 appears to unmask a latent ability to induce MS-like disease in mice.
Building on this and the work of others, Segal and other doctors around the world are now testing in MS patients an experimental drug produced by Centocor that is designed to inhibit IL12 and hopefully suppress attacks.
In the latest paper, published in the journal's "Cutting Edge" section, Segal and neuroscience graduate student Irah L. King use funding from the National Institutes of Health and the National Multiple Sclerosis Society to show that IL12's effects are unexpectedly far-reaching and affect some of the immune system's most powerful cells. The team found that IL12 confers upon CD4+ T-effector cells the ability to overcome suppression by T-regulatory cells, whose job it is to keep the body from attacking itself. Without the order imposed by T-regulatory cells, scientists have shown that animals are more prone to develop autoimmune diseases like MS.
A drug that inhibits IL12, like the one under development by Centocor, could restore the function of the T-regulatory cells, allowing them to be more effective in clamping down on rogue T-effector cells. Such a medication might also be useful in other autoimmune diseases like Crohn's disease, psoriasis, and arthritis, where scientists suspect IL12 also plays a role.
"There are a variety of treatments for MS, but most are only modestly effective," says Segal, associate professor of Neurology and director of Neuroimmunology Research. "We are always looking for better treatments that are more convenient for our patients, with fewer side effects. Inhibiting IL12 offers one potential option."
Segal's work helps explain why MS patients are more likely to suffer a relapse of the disease when they get an infection like the flu. When a person is infected, IL12 levels rise to allow the person to fight off the infection. Segal's work showing that IL12 helps usher harmful white blood cells into the central nervous system clarifies why MS patients sometimes worsen when they get an infection.
http://www.eurekalert.org/pub_releases/2005-07/uorm-wgc071105.php
posted by Bill at 11:50 PM
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