Thursday, January 31, 2008

ATX-MS-1467 - Positive Immunological Data In Multiple Sclerosis

http://www.abnnewswire.net/press/en/47557/ATX-MS-1467.html
Bristol, Germany, Jan 30, 2008 - (ABN Newswire) - Final Phase I/IIa data shows safety and tolerability, plus efficacy
Bristol, UK - 30th January, 2008, Apitope Technology (Bristol) Ltd., the developer of peptide-based therapies for autoimmune diseases and allergy, announces today final results of a Phase I/IIa clinical trial of ATX-MS-1467 to treat Multiple Sclerosis (MS). Immunological analyses showed a significant down regulation of the T-cell response to the autoantigen (myelin basic protein) whilst the important normal immune responses were left unchanged.
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As previously announced, the therapeutic peptide vaccine was found to be safe and well tolerated in Secondary Progressive Multiple Sclerosis (SPMS) patients with no treatment related serious adverse or adverse events reported.
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Although the trial was not designed to show efficacy, there is preliminary evidence of a positive clinical response to ATX-MS-1467 in two of the six patients. One patient with optic neuritis resulting from the neuroinflammatory process involved in MS continues to demonstrate a clinically significant improvement in visual acuity post treatment. Additionally, a second patient has shown improvement in the Gd-enhanced MRI scan indicating a reduction in neuroinflammatory processes in the brain.
"We are extremely pleased with these results in secondary progressive MS patients. The peptides are very well tolerated in this patient group", said Dr Keith Martin, CEO of Apitope. "Also, we now have good indicators that these peptides may be a significant improvement on current therapies available to patients with MS, a disease with huge unmet medical need."
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The immunological analyses showed a reduction of up to 40% in myelin basic protein-induced T-cell proliferation one month after the course of treatment with ATX-MS-1467 while the T-cell response to PPD (a constituent of the BCG vaccine) was unchanged.
"These preliminary clinical and immunological data are very encouraging and support the preclinical and scientific evidence on which this product is based", said Professor David Wraith, CSO of Apitope and Professor of Experimental Pathology at the University of Bristol.
-----------------------------------------------------------------------------------------
Apitope expects to begin a final Phase II trial of ATX-MS-1467 before the fourth quarter this year with full results expected within 24 months of the trial start. This trial will be designed as a double-blind placebo controlled study in MS patients with the more frequently encountered relapsing remitting form of MS.

Along with development of ATX-MS-1467 Apitope is continuing development of a diagnostic blood test for MS and expects to complete the clinical validation in patients with all forms of MS in the next 12 months.
ATX-MS-1467, is a vaccine containing four peptides derived from human myelin basic protein that targets the major histocompatibility complex (MHC) class II molecule and has been specifically designed and developed to treat MS patients. The recently completed ATX-MS-1467 Phase I/IIa open label trial was designed as a dose escalation study to assess the safety and tolerability with all six patients receiving five escalating doses given 7 to 14 days apart of 25, 50, 100, 400 and 800 followed by a repeat of the 800 microgram dose.

ABOUT APITOPE TECHNOLOGY (BRISTOL) LTD Apitope is a biopharmaceutical company engaged in the research and development of treatments for allergy and autoimmune diseases. The Company is developing novel advantaged products representing major advances in therapy and addressing critical unmet needs that can revolutionise the treatment of chronic autoimmune and allergic disorders. Apitope was established at the University of Bristol in January 2002 by Professor David Wraith and initially funded by Mr Richard Daniels.
The company has a patented platform technology for the design of peptide therapeutics (ApitopesTM) to treat autoimmune and allergic diseases. This novel Apitope technology is based on established scientific evidence showing that soluble, synthetic peptides can reinstate tolerance and attenuate pathological immune responses. The therapy is specifically designed from naturally occurring antigenic proteins to selectively inhibit the immune system's harmful attack on the body while preserving the normal immune response to harmful antigens, such as infections. The unique Apitope peptides function as tolerogens, exerting their therapeutic effect via an highly selective immune re-balancing process that, in pre-clinical studies, has been linked to the induction of IL-10 secreting regulatory T cells. Behaving as Antigen Processing Independent epiTOPES (ApitopesTM), the peptides induce tolerance to abnormal immune responses.
The company, initially, is testing the safety and efficacy of ApitopesTM in multiple sclerosis (MS) patients. Its lead product is ATX-MS-1467, a peptide vaccine, which up regulates T cells through the major histocompatibility complex (MHC) class II receptor. The vaccine is potentially a disease-modifying therapy specifically designed from a naturally occurring antigenic protein to selectively inhibit the immune system's harmful attack on the nervous system. The normal immune response to infection is preserved. The ATX-MS-1467 vaccine is an equal parts mixture of four soluble, synthetic peptides (ApitopesTM). The company plans to develop ApitopesTM for other chronic diseases including Type I diabetes, rheumatoid arthritis and the common allergies.
* Apitope's Phase I/IIa protocol for MS was approved by the MHRA in February 2007
* The Company is also developing an MS diagnostic, which is based on its proprietary technology, with a predicted launch date of Q4, 2009
* A peptide vaccine to prevent Factor VIII intolerance is expected to enter clinical trials in late 2008.
Apitope is backed by The Wellcome Trust, Sulis Seedcorn Fund and advised by Innovator Capital.
Further information on the company can be found at: http://www.apitope.com/
Contact:
Apitope Technology (Bristol) Ltd Dr. Keith Martin, CEO +44 117 903 1119 keith.martin@apitope.com
Innovator Capital Limited Kalam Ali +44 20 7297 6840 kalam.ali@innovator-capital.com
The press release can be downloaded from the following link:
LINK: http://hugin.info/138779/R/1186287/237694.pdf
Copyright © Hugin AS 2008. All rights reserved.
Apitope Technology (Bristol) Ltd
http://www.apitope.com/
Stock Identifier: GER.APITOPETECHNOLOGYJan 30, 2008
Asia Business News
http://www.abnnewswire.net
Topic: General Announcement
Sectors: Financial General
http://www.abnnewswire.net/press/en/47557/ATX-MS-1467.html

ATX-MS-1467 - Positive Immunological Data In Multiple Sclerosis
ABN Newswire (press release) - Sydney,NSW,Australia
The peptides are very well tolerated in this patient group", said Dr Keith Martin, CEO of Apitope.
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Wednesday, January 30, 2008

Toward tolerating transplants | Philadelphia Inquirer | 01/28/2008

A Children's Hospital researcher is working to enable patients to accept new organs without taking potent drugs the rest of their lives.

Posted on Mon, Jan. 28, 2008
By Josh Goldstein
http://www.philly.com/inquirer/health_science/weekly/20080128_Toward_tolerating_transplants.html

Inquirer Staff Writer

Organ transplantation is one of the crowning achievements of modern medicine, but surgical success comes at a price.

Recipients must take powerful drugs - with not-infrequent serious side effects that include infections, kidney damage and cancer - for the rest of their lives to prevent rejection of the new organ. Even so, one-third of them will need another transplant within 20 years because their donated organs wear out.

So ever since the first successful transplants five decades ago, finding a way to get patients to accept their new organs without the need for immune suppression - known as graft tolerance - has been a key goal for medical researchers.

At Children's Hospital of Philadelphia, Australian-born pathologist Wayne Hancock is pursuing a solution that so far has had promising results, at least in mice.

"We can induce tolerance," he says - at least in transplanted laboratory mice.

Working on the most basic level of the immune system - the genes that control T cells, the body's main line of defense against alien invaders - Hancock and his team have succeeded in getting mice to accept the transplants as their own following a brief course of drugs that are already approved for other uses. After two weeks, they were drug-free.

"Immune suppression causes really all of our other problems," says Elizabeth Rand, medical director of Children's Hospital's liver transplant program. "Inducing graft tolerance is really the Holy Grail of organ transplantation."

Hancock's latest research, published two months ago in the journal Nature Medicine, has potential beyond transplantation.

It could lead to treatments for autoimmune disorders ranging from inflammatory bowel disease to multiple sclerosis, and perhaps even the asthma and diabetes that afflict millions.

That would be a big plus, but Hancock is most interested in helping the nearly 30,000 Americans who have transplants each year and currently require lifelong immune suppression.

Researchers all over the world are seeking a better approach. Just last week, three brief reports in the New England Journal of Medicine examined inducing tolerance in small numbers of transplant patients under special circumstances.

"Taking the immune system out of the equation would be a big improvement," Karl L. Womer, a physician-scientist at Johns Hopkins University School of Medicine whose research focuses on transplant immunology, says of Hancock's work. "There is definitely a long way to go."

Hancock knows it's one thing to succeed with mice, which lead relatively germ-free lives in the laboratory, and quite another with humans, who are exposed daily to myriad bacteria and viruses.

Still, his approach is promising enough to garner a five-year grant from the National Institutes of Health.

Hancock's goals are simple - to "contribute to the development of more effective and safer ways to . . . prevent transplant rejection with less toxicity and side effects," he writes in a grant proposal.

And he genuinely wants to do good. A nice side benefit is that the hunt for answers is intellectually stimulating and just plain exciting to the Aussie.

In the early 1990s, things seemed much more bleak. He had lost his U.S. visa and was forced to returned to Australia, where he was working in a pathology lab.

Then one Sunday morning in 1992, as Hancock lay awake in bed contemplating a dull future reading routine patient test results day after day after day, the phone rang. Harvard wanted him back in the States to search for solutions to the problem of immune suppression.

Sixteen years later, after a foray into industry with a biotech firm and now with his own lab at Children's Hospital, the 53-year-old pathologist thinks his team is closing in on a real, broadly applicable approach.

Hancock's research is focused on a subset of T cells known as regulatory T cells. Although they are an integral part of the immune system, the balancing act assigned to T-regs is to suppress it, thus preventing the body from attacking itself.

So, for example, tissue samples from mice with a form of inflammatory bowel disease - an autoimmune condition characterized by ulcers in the lining of the colon - reveal very few T-reg cells, and those that are present are not active. To treat these mice, the researchers injected a type of drug known as an HDAC inhibitor. The mice then produced more, and more effective, T-reg cells.

Likewise, mice that had heart transplants and were then treated with HDAC inhibitors developed increased numbers of T-regs. After two weeks of treatment, the mice had accepted the new organs and required no further immune suppression.

The drugs - histone deacetylase inhibitors - were developed for cancer treatment and approved by the Food and Drug Administration for clinical use.

Hancock's research shows that the HDAC inhibitors act on a key gene and the protein it produces to increase T-reg numbers and function. Now Hancock and his team have begun testing their approach on monkeys.

Hancock's findings suggest another possible use beyond treatment: Measuring the numbers and function of a patient's T-reg cells in blood or tissue samples might eventually be used to diagnose autoimmune problems and organ rejection.

So far, his work with regulatory T cells has gotten to the point that others in the field might call intriguing.

"It is an interesting idea and potentially practical approach that awaits confirmation," says Terry Strom, a professor of immunology at Harvard Medical School. "The approach merits serious review and critical follow-up experiments."

Contact staff writer Josh Goldstein at 215-854-4733 or jgoldstein@phillynews.com.
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MBP8298 (BioMS) (RRMS trial)

Lilly Caps Successful Year with Strong Fourth-Quarter Results
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Lilly Caps Successful Year with Strong Fourth-Quarter Results

    --  In December, the company entered into a licensing and development
     agreement with BioMS Medical Corp., granting Lilly exclusive worldwide
     rights to BioMS Medical's lead multiple sclerosis (MS) compound,
     MBP8298. The compound is currently being evaluated in two pivotal
     phase III clinical trials in secondary progressive MS (SPMS) and one
     Phase II clinical trial in relapsing-remitting MS (RRMS). The
     transaction closed in January, 2008.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-29-2008/0004744671&EDATE=

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Susan Hughes remembers the humiliation of her arrest for marijuana possession 12 years ago. And she remembers the anger when a judge couldn't consider her multiple sclerosis when deciding whether to allow charges against her.

Tuesday, January 29, 2008

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Saturday, January 26, 2008

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Girl Switches Blood Type In 'One In Six Billion Miracle'

Friday January 25, 2008

CityNews.ca Staff

Her name is Demi-Lee Brennan and until this week, the world never heard of her. But now the planet will never forget her name. The reason? She's become what medical experts call a 'one-in-six-billion miracle,' and they're trying to figure out how she did it.

The 15-year-old patient received a liver transplant and made history in the process, when her system suddenly changed blood groups from O negative to O positive and took on the immune system of her organ donor. Amazed doctors say it's the world's first known case and if they can solve the riddle of exactly how it happened, it may forever change the way transplants and organ donations are arranged.

"It's like my second chance at life," Brennan admits. "It's kind of hard to believe."

Here's what the experts know so far. The change came when Brennan became ill while on drugs used to prevent her body from rejecting the new organ. Her liver's blood stem cells then went into her bone marrow and took over her immune system, ending the need for the drugs.

"There was no precedent for this having happened at any other time, so we were sort of flying by the seat of our pants," Michael Stormon, a pediatric hepatologist, agrees.

"We now need to go back over everything that happened to Demi-Lee and see why, and if it can be replicated," Stuart Dorney, the hospital's former transplant unit head, told a local Australian newspaper. "We think because we used a young person's liver and Demi-Lee had low white blood cells, that could have been a reason."

The news follows this week's other breakthrough that also promises to end organ rejection. Read more about that here.

http://www.citynews.ca/news/news_18945.aspx

A step closer to creating life out of chemical soup - Los Angeles Times

template_bas

Scientists replicate a bacterium's entire genome with off-the-shelf ingredients. The feat could lead to the production of medicines, industrial products and even renewable fuels.

By Karen Kaplan, Los Angeles Times Staff Writer
January 25, 2008

Using off-the-shelf chemical compounds, scientists for the first time have constructed the entire genome of a bacterium, a key step toward their ultimate goal of creating synthetic life forms, researchers reported today.
The man-made DNA was nearly identical to the natural version on which it was based -- with minor modifications to identify it and render it harmless to people, according to the study in the journal Science.
The research team at the J. Craig Venter Institute in Rockville, Md., is now trying to insert the artificial DNA inside a living cell with the hope that it will take over its host and become the first synthetically created, self-replicating organism.
"This entire process started with four bottles of chemicals," said J. Craig Venter, who has been spearheading the overall project.
Scientists have previously pieced together individual genes and even whole viruses in the lab, but those were not independent life forms. The genome in this study -- from the bacterium Mycoplasma genitalium -- is more than 10 times larger than any previously synthesized.
Researchers in the nascent field of synthetic biology hope to use the method as a blueprint for designing microscopic creatures that can produce renewable fuels, medicines and industrial products.
"It's a cookbook for how to make big things," said Andrew Ellington, a biochemist at the University of Texas at Austin, who was not connected with the study.
Venter, the maverick scientist best known for challenging the federal government's effort to decode the human genome, has been studying M. genitalium for more than a decade.
With only 485 protein-coding genes and very little extraneous DNA, its genome is smaller than that of any other free-living organism.
Venter wants to make it even smaller and find out just how many genes are required to create "a minimal operating system for life."
About 100 of the genes can be removed individually without affecting the bacteria's ability to survive. But that doesn't mean all 100 genes can be deleted simultaneously. To determine how many are superfluous, he plans to make thousands of versions of the bacterium and see which ones can survive.
An organism's genome is made up of varying pairs of four chemicals -- adenine, thymine, cytosine and guanine. These base pairs form the rungs in the spiraling double helix of DNA.
Replicating M. genitalium's entire string of A's, Ts, Cs and Gs in the lab was the first step in Venter's plan.
Nature's version of the bacterium, which causes nongonococcal urethritis and other genital diseases, contains a single circular chromosome that is 580,076 base pairs long.
The research team started out with 101 small fragments of the genome, which were made by three commercial firms that specialize in synthesizing genes and other short DNA sequences.
Each fragment overlapped slightly with the ones on either side.
Then they assembled them into progressively larger chunks.
Four adjoining fragments were combined with an enzyme, which chewed off one strand of DNA at each end. DNA strands naturally pair up, and the overlapping fragments came together spontaneously, said Dr. Hamilton O. Smith, the Nobel Prize-winning biologist who led the team.
The resulting 25 larger pieces were injected into the bacterium Escherichia coli, which made thousands of copies as it divided. The copies were harvested and used in the next stage of the experiment.
The researchers used the same method to combine the 25 pieces into eight larger sections and then paired those up into four bigger segments before they maxed out the capacity of E. coli.
That prompted a switch to a yeast called Saccharomyces cerevisiae, which has a natural tendency to repair broken chromosomes. With the yeast, they were able to combine the four segments into two half-genomes. They made copies and then spliced together the two halves into a complete genome, Smith said.
Along the way, they added five short watermarks to differentiate between the original genome and the copy.
They also modified one of the genes to disable the bacteria's ability to stick to mammalian cells and cause diseases. The final version of the synthetic genome was 582,970 base pairs long. If printed out on paper in 10-point font, the genome would fill 147 pages.
"Reconstructing a natural bacterial genome from scratch is a great technical feat," said Drew Endy, a biological engineer at MIT, who wasn't involved in the study.
The next step for the researchers is to transplant the artificial DNA into a host bacterium and see if it will take over the cell.
Another team at the Venter Institute demonstrated last year that it could convert one species of Mycoplasma into another by replacing all of its DNA. But the species that served as a host in that experiment may not be the best for the synthetic genome, Smith said.
"It's not just a slam-dunk, or we would be announcing it today," Venter said. "But we're confident that they can be overcome, and it's a matter of time before we have it booted up in a cell."
With DNA synthesis technology doubling in power every 12 to 18 months, scientists should be able to create customized bacteria by 2012, Endy said.
"Getting better at building DNA . . . is incredibly important," he said.
The study was funded by Synthetic Genomics Inc. of Rockville, a privately held sister company to the Venter Institute that is designing cells that can produce clean energy.
A green jet fuel is currently being tested, and hundreds of other products could follow, Venter said.
But M. genitalium probably won't serve as the foundation for those future designer organisms because it is too difficult to grow in the lab, Smith said.
karen.kaplan@latimes.com
http://www.latimes.com/news/custom/scimedemail/la-sci-synthetic25jan25,0,3433611,full.story

Wednesday, January 23, 2008

VIDEOMultiple Sclerosis

CBC.ca News - Health

VIDEOMultiple Sclerosis: New research gives hope to some (Runs 12:37)

http://www.cbc.ca/health/

New therapeutic target for treatment of multiple sclerosis
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Tuesday, January 22, 2008

Boost neurosurgery capacity, Ontario urged

LISA PRIEST
From Tuesday's Globe and Mail
January 22, 2008 at 4:19 AM EST
The Ontario government should take aggressive action to help stem the tide of critically ill patients with cerebral hemorrhages being rushed to American hospitals, Ontario's Progressive Conservative health critic said yesterday.
Elizabeth Witmer said the government needs a plan so patients requiring neurosurgical care are able to obtain it here - not in the United States. "There's no effort whatsoever to develop a plan of action," Ms. Witmer said of the Liberal government. "It's really quite appalling to see the increase in the number of patients from 2003-2004 to the present, who are going to the United States."
Her remarks follow a Globe and Mail story on the weekend that showed how, since April, 2006, 157 patients with broken necks, burst aneurysms and other types of bleeding in or outside of the brain have been sent to Michigan and New York State hospitals for care. Back in 2003-2004, fewer than five neurosurgical patients were sent to U.S. hospitals.
Other provinces are also struggling to meet demand. British Columbia sent four patients with spine injuries to Washington State hospitals from May, 2007, to September, 2007. The recruitment of more staff and opening of new beds in that province have since helped alleviate the problem.
Related Articles
Recent
* Ontario reconsiders neurosurgery funding
* Critically ill patients rushed to U.S. for care
The Globe and Mail
Saskatchewan has sent patients to neighbouring provinces such as Alberta, which is working at maximum capacity, for certain specialized neurosurgical services.
But nowhere is the problem worse than in Ontario. Emergency room physicians said they have watched patients deteriorate while trying to locate care for them.
Ontario Health Minister George Smitherman could not be reached for comment yesterday.
However, his press secretary, Laurel Ostfield, said the province does have a plan, one that ensures patients get the care they need and addresses neurosurgical capacity in the province.
To that end, an additional $4.1-million was provided in November to Toronto's University Health Network to handle 100 more neurosurgery cases. As well, the province commissioned a neurosurgery expert panel; it delivered its report late last month.
"We are already seeing positive results from the additional cases that have been funded at the University Health Network," Ms. Ostfield wrote in an e-mail yesterday.
The three main groups of patients sent out of the country include those with the following diagnoses: subdural hemorrhage, a collection of blood on the surface of the brain; intracerebral or intracranial hemorrhage, which is bleeding in the brain caused by the rupture of a blood vessel within the head; and subarachnoid hemorrhage, which occurs when a blood vessel just outside of the brain ruptures, causing the area of the skull surrounding the brain, the subarachnoid space, to fill with blood.
In addition to the extra stress on patients and their families, the cost to treat these patients is far higher than in Canada.
The average Ontario payment in fiscal 2006-07 to U.S. hospitals where the patient's condition was recorded solely as subarachnoid hemorrhage was $126,148, according to Health Ministry figures.
Compare that to Toronto's University Health Network, where the cost to treat a patient whose primary diagnosis is a subarachnoid hemorrhage in fiscal 2006-2007 (not including physician costs) was $43,200.
Recommend this article? 1 votes
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Current Clinical Trials in MS–Open For Enrollment

http://www.unitedspinal.org/publications/msqr/2006/11/15/current-clinical-trials-in-ms/

MSQR 2006 Reader Survey Results »

Current Clinical Trials in MS–Open For Enrollment

A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood Samples for Research Into the Causes of MS and Selected Demyelinating Diseases

Location: Barrow Neurology Clinics at St. Joseph’s Hospital & Medical Center in Phoenix, AZ.

Purpose: This research study is being done to establish a large-scale, multidisciplinary blood and data bank that will be made available to scientists involved in the study of MS and other demyelinating diseases and, in particular, what causes these diseases. The bank will include a collection of blood and associated data from two groups (Cases and Controls)

Eligibility:

Inclusion Criteria:

Cases & Controls:
• At least 18 years of age.

Cases:
• Individuals who have experienced at least one central nervous system (CNS) demyelinating event characteristic of multiple sclerosis (MS), transverse myelitis ™, acute disseminated encephalomyelitis (ADEM), neuromyelitis optica (NMO) or optic neuritis (ON).

Controls:
• Individuals who have not experienced any CNS demyelinating events characteristic of MS, TM, ADEM, NMO or ON and have not been diagnosed with any demyelinating disease.

Exclusion Criteria:

Cases & Controls:
• Individuals with clinical or radiological evidence of stroke, meningitis, neoplastic, peripheral nervous system or primary muscle disease, or other well characterized and defined diseases of the nervous system with the exception of MS, TM, ADEM, NMO, ON.
• Individuals with a history of blood borne pathogens (e.g., viral hepatitis, HIV/AIDS).
• Individuals with a history of allogeneic bone marrow transplant due.

Procedure: Patients who are determined to be eligible will complete an initial visit and followup visits every one to two years for the remainder of their lifespan. Additionally, they will be asked to refer blood related family members with and without MS, TM, ADEM, NMO or ON, as well as unrelated controls, to the study. The relatives and unrelated controls will then have the option to contact the research team in order to be screened. A familial link will be maintained between all family members participating in the study.

Benefit: Patients will not benefit directly by participating in this research. The studies that may be performed with their data and specimens will not be designed to specifically help them and will not be used to make health care decisions for them. However, the knowledge gained from the studies may benefit others in the future.

For Information: Contact Taira Kochar, research coordinator, at 602-406-7711.

A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study, to Compare the Efficacy,Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With RRMS

Location: Barrow Neurology Clinics at St. Joseph’s Hospital & Medical Center in Phoenix, AZ

Purpose: The purpose of this research study is to determine whether or not a higher 40 mg dose of glatiramer acetate (Copaxone®) is safe and more effective in treating multiple sclerosis (MS) than the currently available 20 mg dose of glatiramer acetate.

Eligibility:

Inclusion Criteria:
• 18 to 55 years of age
• RRMS with at least one documented relapse in the 12 months prior to screening and at least two documented
relapses in the 24 months prior to screening
• Relapse free and in stable neurological condition at least 30 days prior to screening

Exclusion Criteria:
• No previous use of GA
• No previous use of Natalizumab
• No IVIG or interferons within 2 months
• No steroids within 30 days
• No chronic use of steroids within 6 months
• No immunosuppressants within 6 months

Procedure: Patients who are determined to be eligible will be randomized to receive either glatiramer acetate (GA) 20 mg or GA 40 mg for the first twelve months of the study. For the second half of the study (Months 12 through 24), all patients in the study will receive GA 40 mg. Patients will come to the MS Research Office at Barrow Neurology Clinics for 12 scheduled visits over approximately 2 years. In addition, some patients may have additional scheduled visits. Study visits will include the following: physical and neurological examinations, MRIs, ECGs and laboratory tests.

Benefit: It is hoped that patients taking the 40 mg dose will do better with their multiple sclerosis (MS) than patients taking the 20 mg dose. During the course of this study, a patient’s MS may improve, remain the same or worsen.

For Information: Contact Mary Catherine Parker, RN, research coordinator, at 602-406-7711.

Achieve Study––Assessing Copaxone®Versus High Dose Interferon—Evaluation of Efficacy

Location: Multi-centers throughout the US and Canada.

Purpose: A phase IV study to compare the total number of relapses experienced by patients randomized to maintain treatment on high-dose INF therapy compared to those who were transferred to Copaxone® (glatiramer acetate) in patients with relapsing MS.

Eligibility:
• Men and women ages 18–50
• Diagnosis of clinically definite MS with a relapsing disease course
• Must be on either Rebif® or Betaseron® for a minimum of 1 year prior to
study entry
• Relapse history to meet the eligibility criteria of the study.

Procedures:
• Participants will receive injections of either INF or Copaxone for 3 years
• MRIs will be performed every 6 months for the duration of the study.

Benefit: Primary outcome will be the analysis of the difference in relapse rate between the two groups of patients.

For Information: Please call 1-866-550-0614 or go to www.centerwatch.com or www.nationalmssociety.org

Biogen IDEC Trial: Multi-Centered, Open Label Study of Approximately 300 Relapsing MS Patients That Will Compare B-IFN Induced Biomarker Response Following B-IFN Injection In Neutralizing Antibody Positive vs. Antibody Negative Patients

Location: Phoenix, AZ.

Purpose: To compare baseline B-IFN induced MxA mRNA response in neutralizing antibody positive vs. antibody negative patients.

Eligibility: Patients must currently be treated with the same interferon for 12–48 months. Patients must be 18–65. Patients must not have had prior testing for neutralizing antibodies. Patients can not be on combination therapies.

Procedure: 6-month study with three clinic visits and three blood draws at Barrow Neurology Clinics located at St. Joseph’s Hospital in Phoenix, AZ.

For Information: Mary Catherine Parker, RN, CCRC, at 602- 406-6287 or email mary.parker@chw.edu

CombiRx Phase 3 (NIH-NINDS # 1 U01 NS 45719-01 A1)

Location: 85 sites in the US and Canada.

Purpose: National Institutes of Health sponsored, multi-center, double-blind, randomized study comparing the combined use of Interferon Beta-1a and Glatiramer Acetate to either agent alone in patients with relapsing-remitting multiple sclerosis.

Eligibility: Men and women 18–60 years of age with relapsing-remitting MS who have experienced at least two relapses in the previous three years and have never taken either Glatiramer Acetate or Interferon Beta-1a.

Procedure: The subject’s duration in the study will be 36 months. Upon enrollment, subjects will begin simultaneously on two medications—all subjects will receive at least one active medication. There is no placeboonly group.
• Interferon Beta-1a intramuscular (IM) weekly and subcutaneous (SQ) placebo daily (25% of group)
• Glatiramer Acetate SQ daily and IM placebo weekly (25% of group)
• Interferon Beta-1a IM weekly and Glatiramer Acetate SQ daily (50% of group)

Benefit:The primary objective of this study is to determine whether combined treatment with Interferon Beta-1a IM once weekly and Glatiramer Acetate SQ daily is more effective than either agent alone in treating Relapsing-Remitting MS as determined by reduction in relapse rate. Study drug and all study specific evaluations are provided at no cost to subjects. Parking or reimbursement for transportation will be provided for up to $20 with a receipt.

For Information:
• Call toll free 1-866-848-3088
• If you are within 50 miles of West Los Angeles, CA, Call Dr. Baumhefner at (310)-268-3013
• MS Care Center, Hospital for Joint Diseases, New York, NY. Call Tamar Fromm at 212-598-6585
• Barrow Neurological Institute, Phoenix, AZ. Call Oana Sebescu at 602-406-6291
• Mt. Sinai School of Medicine, New York, NY. Call 866-848-3058

Combination Therapy Trial for RRMS

Teva Neuroscience, Inc., is conducting a clinical trial to evaluate whether a combination therapy accelerates and enhances the effectiveness over conventional therapy for patients with relapsing-remitting multiple sclerosis (RRMS).

Protocol #: NC-100

Location: Multi-centers throughout the US.

Eligibility: Definite diagnosis of RRMS; males and females between the ages of 18 and 55 years old; steroid treatment-free for at least 28 days; ability to participate in study for 15 months; ability to undergo MRI scans of the brain.

For Information:
• MS Hub Medical Group, Seattle, WA—contact Tim Monahan at 206-262-0110 ext. 110

Improving Memory in Patients With MS

Location: University Hospital and Medical Center, Stony Brook, NY; Rochester, NY; Buffalo, NY; Rhode Island.

Purpose: This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept®) has been FDA-approved for improving memory and learning in individuals with Alzheimer’s disease.

Eligibility: Women and men, 18–56 years of age, with unequivocal diagnosis of MS, Expanded Disability Status Scale (EDSS) score of 0 to 6.5, stable neurologic function for at least 30 days prior to study entry, who agree to continue all current medications for study duration, and have Rey Auditory Verbal Learning Test score in the low normal range or below.

Procedure: Patients meeting the above criteria will be randomly assigned to receive either donepezil or placebo for 24 weeks. Participants will complete memory and cognitive tests at the beginning and end of the 24-week period.

Benefit: This study may lead to new therapy to enhance the verbal memory function in individuals with MS.

For Information: Call Patricia Melville, RN, at the University Hospital and Medical Center in Stony Brook, New York, at 631-444-8164, or via e-mail: patricia.melville@stonybrook.edu

Randomized, Double Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin (Lipitor®) in Patients With Clinically Isolated Syndromes and High Risk of Conversion to MS

Location: Phoenix, AZ.

Purpose: To determine if atorvastatin is effective in relapsing-remitting MS.

Eligibility:
• Men and women ages 18–50
• No previous neurological history
• Never been on immunological therapy for MS.

Procedure: Phase II randomized, double blind, placebo-controlled clinical trial. A 3:2 randomization of drug to placebo. Patients not on placebo will take 80 mg/day of atorvastatin.

Benefit: May lead to a new treatment for MS.

For Information: If you live within a 50-mile radius of Phoenix, AZ, contact research coordinators at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center by phone at 602-406-7711.

Stem Cell Therapy for Patients With MS Failing Interferon A Randomized Study

MS is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e., interferon, copaxone, or mitoxantrone) in patients with inflammatory (relapsing) MS despite treatment with interferon.

Eligibility:

Inclusion Criteria:
1. Age between 18–55, inclusive
2. Diagnosis of MS using Poser criteria of “clinically definite” MS
3. An EDSS of 2.0 to 6.0
4. Inflammatory disease despite primary disease modifying therapy with at least 4 months of interferon. Inflammatory disease is defined by either MRI showing gadolinium enhancing lesions or clinically as acute relapses treated with IV solumedrol. Failure is defined as two or more clinical relapses with documented neurological changes within one year prior to the study. (Note: Relapses must have required treatment with corticosteroids). Failure may also be defined as one relapse within the year prior to the study if there is evidence on MRI of active inflammation (i.e., gadolinium enhancement)

Exclusion Criteria:
1. Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.

2. Prior therapy with mitoxantrone.

3. Prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix. Other malignancies for which the patient is judged to be cured, such as head and neck cancer, or breast cancer will be considered on an individual basis.

4. Positive pregnancy test.

5. Inability or unwillingness to pursue effective means of birth control. Effective birth control is defines as 1) refraining from all acts of vaginal intercourse (Abstinence); 2) consistent use of birth control pills; 3) injectable birth control methods (Depo Provera, Norplant); 4) tubal sterilization or male who has undergone vasectomy; 5) placement of an IUD (intrauterine devise); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam.

6. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.

7. FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary).

8. DLCO < 50% of predicted.

9. Resting LVEF < 50%.

10. Bilirubin> 2.0mg/dl.

11. Serum Creatinine> 2.0 mg/dl

12. Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to iron compounds/medications.

13. Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams.

14. Diagnosis of primary progressive MS.

15. Platelet count < 100,000/ul, WBC < 1,500 cells/mm3.

16. Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible.

17. Active infection except asymptomatic bacteruria.

Procedure/Benefit: To compare the clinical outcomes for patients treated with standard therapy (including interferons, steroids, IVIG and chemotherapy), vs. those who undergo stem cell transplantation.

Contact Information: Kathleen Quigley, RN, BSN, MBA, phone: 312-908-0059

Treatment of MS Using Over-the-Counter Inosine

Location: Hospital of the University of Pennsylvania, Philadelphia, PA.

Purpose: The purpose of this study is to determine whether raising low levels of the natural antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic effect on the progression of RRMS and secondary progressive MS.

Eligibility: Males and females, 18–60 years of age. Non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test result within 60 days before the first dose of study material. Males and females must practice adequate contraception, in the judgment of the investigator, during the course of the study. Subjects must have a diagnosis of clinically definite relapse-remitting MS based on medical history, physical examination, laboratory test results, and neurologic examination, and have had one clinical relapse in the last year. Alternatively, subjects may have clinically probable MS characterized by one attack and the presence of at least four lesions on MRI within 12 months before the initial baseline evaluation. Subjects must have an EDSS test result of less than or equal to 5.0 within 60 days before the first dose of study material. Subjects will have serum uric acid levels less than 5 mg/dl. There are also several exclusion criteria.

For Information: Contact Vanessa Zimmerman by phone at 215-349-5162, or via e-mail: vanessa.zimmerman@uphs.upenn.edu

Zenapax® to Treat MS

Location: National study sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), based in Bethesda, MD.

Protocol #:04N0019

Purpose: To examine the safety and effectiveness of Zenapax (a laboratorymanufactured antibody) in treating MS.

Eligibility:
• Women and men aged 18–65 years
• Persons with relapsing-remitting or secondary progressive MS who have had more than one relapse within 18 months preceding study enrollment
• EDSS score between 2.5 and 6.5, inclusive
• Have failed standard IFN-beta therapy
• Must have at least two Gd-enhancing lesions or greater in the three pre-treatment MRI scans (an average of at least 0.67 Gd enhancing lesions per scan).

Procedures: Three MRI scans over initial 2 months to evaluate disease activity. During treatment, receive seven IV infusions of Zenapax––the first two will be given 2 weeks apart; the next five will be given once a month. Before each infusion, participants will have two MRI scans, one using standard procedure and one using gadolinium. Blood and urine samples will be taken at each visit. There will be skin tests. A lumbar puncture will be done at the beginning and at end of the treatment phase. Lymphocytes will be collected before, during, and after treatment.

Benefit: May lead to a new treatment for RRMS or SPMS.

For Information: Contact the NIH Patient Recruitment and Public Liaison Office, via toll-free telephone at 800-411-1222, or via e-mail: prpl@mail.cc.nih.gov

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Sunday, January 20, 2008

Gene studies home in on lupus cause | Health | Reuters

Sun Jan 20, 2008 3:16pm EST

WASHINGTON (Reuters) - Four separate studies published on Sunday identify a series of genes linked with lupus, a debilitating illness that can affect various parts of the body at once.

The studies show that, as suspected, the immune system is going haywire in lupus. But it also points to some previously unsuspected causes of the once-mysterious disease.

And the findings may not only help scientists find better treatments for the disease -- but may help in diagnosing it in the first place, as it is easily confused with other conditions.

Systemic lupus erythematosus, lupus for short, affects at least 1.4 million people in the United States and 50,000 in Britain, advocacy groups say.

It can damage the joints, kidneys, heart, lungs, brain and blood and is marked sometimes by a characteristic butterfly-shaped rash on the face.

Three studies in the journal Nature Genetics and a fourth in the New England Journal of Medicine identify several areas of DNA that carry mutations in people with lupus and their relatives.

"These results suggest biologic pathways that help us understand the condition better and suggest additional genetic and non-genetic triggers," Carl Langefeld, director of the Center for Public Health Genomics at Wake Forest University in North Carolina and one of the study coordinators, said in a statement.

"In addition, they will help delineate the genetic distinctions between rheumatoid arthritis, lupus and other autoimmune diseases, which could lead to earlier, more accurate diagnoses."

One international team of researchers studied the DNA of more than 6,700 women, including people with lupus, their relatives, and unrelated people with no evidence of the disease. Among the four studies, about 10,000 people were tested and 13 different genes were implicated.

"Overall, these papers confirm what investigators have been finding over the past decades," said Dr. Mary Kuntz Crow of the Hospital for Special Surgery in New York.

"They show that many aspects of the immune system are involved in the development of the disease, but they also provide a new level of detail regarding the specific molecular pathways that contribute."

MISSED GROUPS

Some of the genes also apparently contribute to blood vessel function and some have unknown roles, the researchers said.

In a commentary in the New England Journal of Medicine, Crow noted that the studies all miss the biggest group of people affected by lupus.

"In the major studies, all of the subjects were of European descent, but lupus is most severe in people with African, Asian and Hispanic backgrounds," Crow said in a statement.

"We need to confirm that these same genes are involved in all of our patient populations and identify any distinct genes that might be involved in those populations at greatest risk for poor outcomes."

Timothy Vyse of Imperial College London said the studies might help researchers develop better treatment.

"Lupus is a complex disease, which is hard to diagnose, and it can cause many different and unpredictable problems for patients. Living with lupus can be really tough," Vyse said in a statement.

"We currently can treat the disease by suppressing the immune system, but we urgently need to understand in much more detail what goes wrong with the immune system so that we can design better treatments."

(Reporting by Maggie Fox; Editing by Eric Beech)

http://www.reuters.com/article/healthNews/idUSN2033315020080120?feedType=RSS&feedName=healthNews&rpc=22&sp=true
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Potential Stem Cell Treatments Following Discovery Of 'Creator' Gene For Cerebral Cortex
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Hospital Protocols To Determine Brain Death Not Consistant With American Academy Of Neurology Guidelines
A survey of some of the top hospitals in the country has found that protocols followed to determine brain death differ significantly among those institutions. In the journal Neurology, a team of researchers reports finding that brain death protocols at hospitals cited as top neurology and neurosurgery centers by U.
Brain Protein Reduces Alzheimer's Plaques In Mice
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News-Medical-Net Wed, 16 Jan 2008 11:46 AM PST
By comparing the DNA of patients with multiple sclerosis whose symptoms are reduced by interferon beta therapy to the DNA of those who continue to experience relapses, researchers may have identified important genetic differences between the two, according to an article posted online that will appear in the March 2008 print issue of Archives of Neurology.
DNA Analysis Could Help Customize Treatments for MS
HealthDay via Yahoo! News Wed, 16 Jan 2008 9:09 AM PST
WEDNESDAY, Jan. 16 (HealthDay News) -- Genetic differences might explain why some multiple sclerosis (MS)
DNA Analysis Could Help Customize Treatments for MS
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Woman heads to China for stem cell treatment of multiple sclerosis

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Saatchi & Saatchi Consumer Health+Wellness Wins Third New Business ...
Business Wire (press release) - San Francisco,CA,USA
The new win as agency of record is Acorda Therapeutics (NASDAQ: ACOR) a biotechnology company that is developing Fampridine-SR, which is currently in Phase ...
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Multiple Sclerosis Response To Treatment May Vary Depending On Patients' Genes
Researchers compared the DNA of multiple sclerosis (MS) patients whose symptoms were reduced by interferon beta therapy to the DNA of patients whose symptoms were not reduced, patients who continued having relapses.
Novel Neural Stem Cell Type Identified
Researchers from the Sloan-Kettering Institute, led by Dr. Lorenz Studer, have discovered a novel type of neural stem cell, which has a broader differentiation potential than previously identified neural stem cells.
Dopamine Involved In Aggression
New research from Vanderbilt University shows for the first time that the brain processes aggression as a reward - much like sex, food and drugs - offering insights into our propensity to fight and our fascination with violent sports like boxing and football.
A Good Night's Sleep Could Improve Long-term Memory, UK
Scientists from the Medical Research Council's Anatomical Neuropharmacology Unit (ANU) at the University of Oxford have discovered evidence that sleep is important for the stabilisation of memory.
Pleasure Experience Of Wine Goes Up With Price
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Study Examines Decision Making Deficits In Older Adults
We often read or hear stories about older adults being conned out of their life savings, but are older individuals really more susceptible to fraud than younger adults? And, if so, how exactly does aging affect judgment and decision-making abilities? Recent work led by University of Iowa neuroscientist Natalie Denburg, Ph

Wednesday, January 16, 2008