Drug stops multiple sclerosis - but sufferers can't get it!
News-Medical-Net Tue, 29 Nov 2005 3:30 PM PST
Cris Kerr highlights Naltrexone in her latest issue of 'Case Health - Health Success Stories'.

Dendritic cells offer new therapeutic target for drugs to treat MS and other autoimmune disease EurekAlert! Tue, 29 Nov 2005 2:07 PM PST Scientists at the Johns Hopkins Kimmel Cancer Center have found that a gene pathway linked to a deadly form of leukemia may provide a new way to treat autoimmune diseases, including multiple sclerosis. Their tests in cell cultures and mice suggest that blocking the pathway by interfering with a blood cell growth gene, known as FLT3, targets an immune system cell often ignored in favor of T-cell

Dendritic Cells Offer New Therapeutic Target for Drugs to Treat MS Newswise Tue, 29 Nov 2005 2:25 PM PST Scientists have found that a gene pathway linked to a deadly form of leukemia may provide a new way to treat autoimmune diseases, including multiple sclerosis. Their tests suggest that blocking the pathway by interfering with a blood cell growth gene targets an immune system cell often ignored in favor of T-cell targets in standard therapies.

Yale School of Medicine Focuses Top Scientists on Neurodegenerative Diseases Yale University Tue, 29 Nov 2005 12:36 PM PST New Haven, Conn. — Yale School of Medicine, accelerating the pace of research on neurodegenerative diseases such as Alzheimer’s, Parkinson’s and multiple sclerosis, today announced the launch of an interdepartmental program in Cellular Neuroscience, Neurodegeneration and Repair (CNNR).

PS Double Blind Trials For Memory RedNova Wed, 30 Nov 2005 5:49 AM PST By Anonymous Trials Against Age-Associated Memory Impairment 1. Crook and collaborators, USA and Italy.17 T. H. Crook and five co-researchers did this multicenter U.S. trial with 149 patients who fit the criteria for age-associated memory impairment (AAMI).

30 November 2005 PharmiWeb Wed, 30 Nov 2005 4:55 AM PST Resources | Features | HIV doctors underestimate patients’... Patients who could benefit from injectable therapies are a lot less needle-phobic than doctors assume, according to research conducted by pharmacist and behavioural scientist Professor Robert Horne.

Dilemma on prescriptions The Scotsman: Health Tue, 29 Nov 2005 4:30 PM PST THE Labour-Lib Dem coalition has came under pressure from its own backbenchers to publish its alternative to Socialist plans to scrap all prescription charges.

Honors & Awards UCSF Today Wed, 30 Nov 2005 0:36 AM PST Leslie Z. Benet , professor of biopharmaceutical sciences and pharmaceutical chemistry, UCSF School of Pharmacy: Received the doctor honoris causa from the University of Athens on Oct. 7, 2005. This is the highest honorary title awarded by the university.

Dear Mr. ##########:

Thank you for your inquiry regarding the biologic product, Tysabri
(Natalizumab). Tysabri is currently not approved for sale in Canada.

Permission from the manufacturer has been received to disclose that a new
drug submission for Tysabri has been filed to Health Canada. The submission
is currently under priority review.

Tysabri is not available through the Special Access Programme (SAP). Access
to Tysabri is currently limited to ongoing clinical trials due to product
availability.

If you'd like additional information concerning ongoing clinical trials,
please contact the manufacturer, Biogen Idec Inc. directly.

Sincerely,

Georgette Roy, B.Sc., MBA
Manager
Biotherapeutics & Quality Regulatory Affairs Division
Biologics & Genetic Therapies Directorate
Health Products & Food Branch
Health Canada

The current clinical evaluation process is fraught with inefficiencies, resulting in exploding development costs and a compound failure rate of more than 80%. A New Paradigm for Clinical Development: The Clinical Trial in 2015 is a new CHA Advances Report that outlines an innovative and imaginative strategy for reinventing clinical development, and demonstrates why a complete overhaul of the clinical trials process is both necessary and feasible from a conceptual, technical and logistical point of view.

To view a table of contents for this report, please visit
http://www.advancesreports.com/all_reports/2005_59_Clinical_Trials/table_of_contents.html

A New Paradigm for Clinical Development: The Clinical Trial in 2015 proposes a bidirectional approach to accelerate the clinical process and make it more effective. These two avenues, which can be summarized as revamping trial design and as truly pervasive modelling and monitoring driven by information technology, are fundamentally different from each other but need to be implemented in a closely linked fashion. Though radical in effect, none of these changes would involve concepts or technologies that are unknown today.

According to the strategy laid out in the report, the following changes are required:

• Phase I will assume a new role as a brief confirmatory testing stage for the model for drug-human interactions that the sponsor has proposed.
• Phases II and III will merge into a single advanced-stage human testing phase involving fewer patients than today, relying on relatively small patient populations that are highly homogenous with respect to key criteria of pharmacological response.
• Systematic post-marketing studies and a significantly improved and extended post-marketing surveillance system that goes far beyond adverse event reporting will be integrated into a post-marketing monitoring phase that documents real-life use of the newly licensed drug.

These new processes will be made possible through holistic mathematical models such as the "virtual patient" (representing variants of target patients of both sexes, different ethnicities, various ages, and with medical conditions that typically coexist in this target population), extensive biomarker monitoring, and "pervasive computing" that will rely on the concept of seamless capture of every elementary act and equally seamless worldwide data exchange, driven by global standards.

With a full implementation of all envisaged changes by the year 2015, the stage would be set for a new world of drug development:

• The pre-approval clinical trial phase might be shortened to about three years and 40-50% of all candidate compounds that enter this stage could complete it, with the majority of the failures occurring in the early human validation phase.
• The crucial function of the advanced-stage human testing phase will be to determine whether efficacy is sufficiently superior over the established standard of therapy to warrant the cost of launch and the mandated post-marketing monitoring.
• Developers recoup development costs earlier and enjoy a longer life cycle under patent protection, but also benefit from more and closer attention to real-life use of the newly licensed drug.

For more information and pricing for A New Paradigm for Clinical Development: The Clinical Trial in 2015, please visit http://www.advancesreports.com/all_reports/2005_59_Clinical_Trials/table_of_contents.html or contact Cindy Ohlman at cohlman@advancesreports.com or 781-547-0202.

CHA Advances Reports are written by experts who collaborate with CHA to provide a series of reports that evaluate the salient trends in pharmaceutical technology, business, and therapy markets.

CHA Advances Reports, 1000 Winter Street, Waltham, MA 02451

http://www.advancesreports.com

Medical Condition News

Published: Saturday, 26-Nov-2005

Printer Friendly Email to a Friend

An international panel of neurologists has updated the current guidelines for diagnosing multiple sclerosis (MS), strengthening the role of magnetic resonance imaging (MRI). The guidelines, published in the Annals of Neurology, update the "McDonald criteria," created five years ago and named after the chair of the previous panel, Prof W. Ian McDonald of the Institute of Neurology in London. "We hope, and trust, that these revisions will allow an even earlier diagnosis of MS, without any loss of diagnostic accuracy," said Chris H. Polman, M.D., of the Free University Medical Center in Amsterdam, The Netherlands, and chair of the current panel. Multiple sclerosis is an enigmatic disease of the nervous system and results in the loss of myelin, a substance that normally insulates nerve fibers and speeds electrical conduction through the fibers. Depending on which nerve fibers are hindered, patients can experience problems ranging from weakness and clumsiness to numbness, visual disturbances, and even emotional and intellectual alterations. In some patients, MS manifests itself in cycles of relapse and remission, while in others the disease progresses steadily. "The changes in diagnostic criteria for primary progressive multiple sclerosis is particularly helpful," said Robert P. Lisak, M.D., of Wayne State University in Detroit, Michigan, and chair of the American Neurological Association's public information committee. "The ability to make the diagnosis of multiple sclerosis early and accurately is important for both patient care and for clinical research including clinical trials of new treatments." There is increasing evidence that MS drugs such as interferon beta and glatiramer acetate are most effective when started early in the disease course. The original McDonald Criteria were the first to incorporate MRI testing into the traditional tool kit of neurological history and examination, along with various laboratory exams. Brain imaging can show physicians the damaged sites (termed 'lesions') in the brain and spinal cord. "A series of studies performed during the last few years, with improved techniques for spinal cord MRI, shows that it is a powerful tool not only to demonstrate MS lesions, but also to exclude alternative diagnoses," said Polman. The new criteria also conclude that only two separate MRI scans, rather than three, are needed to evaluate whether the disease is progressing. http://www.interscience.wiley.com/journal/ana

A Man's Ideal Waist Size Is...

...less than 37 inches. Once you hit this threshold, your risk for diabetes increases significantly. A simple tape measure may be the best predictor yet of a man's risk of developing diabetes in midlife. A new study from the Johns Hopkins Bloomberg School of Public Health in Baltimore, Md., concludes that once a man's waist size balloons past 34 inches, his risk for diabetes goes up, report Men's Health and HealthDayNews.

When it comes to your good health, there's a new measurement your doctor may want: your waist circumference. Find out what it says about you.

Specifically, a waist size of 34 to 36 inches doubles the risk of diabetes, while a waist size of 36 to 38 inches nearly triples the risk. It gets worse. A waist size of 38 to 40 inches means there is five times the risk, and anything over 40 is 12 times the risk. Who knew love handles could be so dangerous? While a 34-inch waistline may not be attainable, don't worry. The researchers say the new magic number is 37 inches or less.

If you weigh too much, this might be why. Beware a hidden ingredient in your favorite packaged foods! It's making you fat--and you don't even know it's there.

The data were collected from 27,270 men who were tracked over 13 years as participants in the Harvard Health Professionals Follow-Up Study. Led by Dr. Youfa Wang, the researchers determined that waist circumference is a far more useful tool than the Body Mass Index (BMI), which is a weight-to-height ratio for assessing who is most at risk for type 2 diabetes. The difference is that the waist size measures abdominal fat, a key risk factor.

Not all body fat is created equal. Find out what kind of body fat is the most dangerous--and how it could lead to an early death.

Fully 80 percent of the men in this study who developed type 2 diabetes had a BMI of 25, which is the cut-off for being overweight, but half had a waist circumference of 40 inches or higher. Men whose waistlines were this big and also had a BMI of 30 or higher, putting them in the obese category, had more than twice the risk of developing diabetes than those who had either a high BMI or a high waist circumference (but not both). The study findings were published in the American Journal of Clinical Nutrition.

Stop your hunger! These five foods really do control your appetite and suppress cravings--without adding calories.

http://www.nlm.nih.gov/medlineplus/news/fullstory_28211.html

United Press International

Monday, November 21, 2005

BOSTON, Nov 21, 2005 (UPI via COMTEX) -- A Harvard University survey finds 42 percent of about 930,000 ambulatory care Massachusetts patients were prescribed medicines with black box warnings.

Black box warnings appear on the label of certain drugs, highlighting special problems, especially serious ones. The warnings -- the Federal Food and Drug Administration's strongest label for high-risk medicines -- provide physicians with information concerning potential medical complications associated with a specific pharmaceutical.

Researchers from the Harvard Medical School, Harvard Pilgrim Health Care and colleagues found physicians' compliance with such recommendations is highly variable, suggesting better methods are needed for ensuring the safe use of medications.

In the categories studied, physicians' non-compliance with the warnings ranged from 0.3 percent to 49.6 percent.

The results of the study are reported online at the Web site of the journal Pharmacoepidemiology and Drug Safety.

Multiple Sclerosis
In the Spotlight | More Topics | Specials at About.com

	from Sarah Beaubien For most MS symptoms, there are now a range of drug choices on the market. Choosing the right one for you is often done by trial since medications affect each individual in a different way.
In the Spotlight

Comparison Chart for Relapsing Treatment There are four types of treatment on the market today for relapsing-remitting MS. Tolerance for frequency of injections and for side effects will probably determine which medication is right for you...read more		More Topics Neurovax Detrol LA Novantrone Drugs for Sexual Dysfunction MS FAQ MS Glossary
Comparison Chart for Spasticity Medications The general location and severity of spasticity will likely determine the type of medication prescribed. Some drugs are best taken at night...read more
Options for Fatigue Treatment Depending on the healthcare provider and the individual being treated, there are several ways to approach treatment of fatigue...read more

Sponsored Links

Featured Offer

Specials at About.com

CELEBRITY ENTREPRENEURS - Learn How They Did It Oprah Winfrey Hugh Hefner Howard Hughes More Famous Entrepreneurs... Poll Results: Most Admired Entrepreneur

Visit Related About GuideSites:

Search About

More Newsletters: To sign up for more free newsletters on What You Need to Know About your favorite topics, visit: http://talk.about.com You are receiving this newsletter because you subscribed to the About Multiple Sclerosis newsletter as fooledbyasmile@MOUNTAINCABLE.NET. If you wish to change or remove your email address, please visit: http://about.com/nl/usgs.htm?nl=ms&e=fooledbyasmile@MOUNTAINCABLE.NET About respects your privacy. Our Privacy Policy. Our Contact Information. 249 West 17th Street New York, NY, 10011 © 2005 About, Inc.

http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=12556

FREE! Download Windows Media Player

PORTLAND, Ore. (Ivanhoe Broadcast News) -- You've heard fish oil is good for you. Some studies even show it may prevent Alzheimer's and heart disease. Now, doctors want to know if it can decrease depression in a specific group of patients.

Simply putting on makeup can be difficult for Kendall Minter. She has multiple sclerosis -- a disease that causes double vision, numbness in her hand -- and also depression. "I just get stuck in this cycle of doubt and just sadness, and I don't want to do anything about it," she says.

Minter's antidepressant doesn't work as well as she'd like, so everyday, as part of a clinical trial, she also takes six grams of fish oil.

Lynne Shinto, N.D., a naturopathic researcher at Oregon Health & Science University in Portland, says the fish oils, just with MS, look promising. People with MS have high levels of inflammation in their blood, which could cause depression.

In a pilot study, Shinto gave fish oil to ms patients to see if it could decrease those levels. "We gave them fish oils for three months, and we looked at the same marker three months later, and we see that the levels decrease," she tells Ivanhoe. Their inflammation levels dropped by about 50 percent.

"Then, what we did is we took them off fish oil for three months, and we looked at the same marker," Shinto says. "We see that the levels go back up, which is what we expect if they're not taking the fish oil." Now, Shinto and colleagues are conducting another study to find out if the fish oil reduces depression and other symptoms of MS.

Minter is excited about the new study. "I thought it couldn't hurt, so you know, if it helps, then it's a bonus," she says, and she hopes it will also be a bonus for the up to 60 percent of MS patients who suffer depression.

So far, the only side effect is a fishy aftertaste and an upset stomach. If you take a fish oil supplement, you should look on the label to make sure it contains no mercury or other heavy metals. Shinto says there is some evidence that fish oil can help patients with depression who don't have MS, but more research needs to be done to confirm that. The new study is funded by the National Institutes of Health and is now enrolling.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

If you would like more information, please contact:

MS Center of Oregon
Oregon Health and Science University
3181 SW Sam Jackson Park Rd L217
Portland, OR 97239
(503) 494-5759

Related Articles in Archives: Multiple Sclerosis Executive Summary: Diagnosis, Drugs and Alternatives The Female Sexual Experience -- White Paper Nighty Night: Unraveling the Mystery of Dreams and Sleep Disorders Coping After a Stroke -- Full-Length Doctor's Interview Stem Cell 2005 Executive Summary: Advances and Their Controversy Phone Therapy Helps Depression in MS Religion and Depression The Healthy Side of Sex -- White Paper Ancient Healing -- 2004 White Paper

IVANHOE EXTRAS For additional research on this article, click here.

[ Back to Neurological Disorders Channel Home ]

http://www.medicalnewstoday.com/medicalnews.php?newsid=33463

Category: Multiple Sclerosis News
Article Date: 17 Nov 2005

An international panel of neurologists has updated the current guidelines for diagnosing multiple sclerosis (MS), strengthening the role of magnetic resonance imaging (MRI). The guidelines, published online November 10, 2005 in the Annals of Neurology (interscience.wiley.com/journal/ana), update the "McDonald criteria," created five years ago and named after the chair of the previous panel, Prof W. Ian McDonald of the Institute of Neurology in London.

"We hope, and trust, that these revisions will allow an even earlier diagnosis of MS, without any loss of diagnostic accuracy," said Chris H. Polman, M.D., of the Free University Medical Center in Amsterdam, The Netherlands, and chair of the current panel.
v Multiple sclerosis is an enigmatic disease of the nervous system and results in the loss of myelin, a substance that normally insulates nerve fibers and speeds electrical conduction through the fibers.

Depending on which nerve fibers are hindered, patients can experience problems ranging from weakness and clumsiness to numbness, visual disturbances, and even emotional and intellectual alterations. In some patients, MS manifests itself in cycles of relapse and remission, while in others the disease progresses steadily.

"The changes in diagnostic criteria for primary progressive multiple sclerosis is particularly helpful," said Robert P. Lisak, M.D., of Wayne State University in Detroit, Michigan, and chair of the American Neurological Association's public information committee. "The ability to make the diagnosis of multiple sclerosis early and accurately is important for both patient care and for clinical research including clinical trials of new treatments."

There is increasing evidence that MS drugs such as interferon beta and glatiramer acetate are most effective when started early in the disease course.

The original McDonald Criteria were the first to incorporate MRI testing into the traditional tool kit of neurological history and examination, along with various laboratory exams. Brain imaging can show physicians the damaged sites (termed 'lesions') in the brain and spinal cord.

"A series of studies performed during the last few years, with improved techniques for spinal cord MRI, shows that it is a powerful tool not only to demonstrate MS lesions, but also to exclude alternative diagnoses," said Polman.

The new criteria also conclude that only two separate MRI scans, rather than three, are needed to evaluate whether the disease is progressing.
Article: "Diagnostic Criteria for Multiple Sclerosis: 2005 Revisions to the 'McDonald Criteria'," by Chris H. Polman, Stephen C. Reingold, Gilles Edan, Massimo Filippi, Hans-Peter Hartung, Ludwig Kappos, Fred D. Lublin, Luanne M. Metz, Henry F. McFarland, Paul W. O'Connor, Magnhild Sandberg-Wollheim, Alan J. Thompson, Brian G. Weinshenker, and Jerry S. Wolinsky, Annals of Neurology; Published Online: November 10, 2005 (DOI: 10.1002/ana.20673).

The Annals of Neurology, the preeminent neurological journal worldwide, is published by the American Neurological Association, the world's oldest and most prestigious neurological association. The 1,500 members of the ANA--selected from among the most respected academic neurologists and neuroscientists in North America and other countries--are devoted to furthering the understanding and treatment of nervous system disorders. For more information, visit http://www.aneuroa.org.

John Wiley & Sons, Inc.
http://www.interscience.wiley.com

See how the revolutionary treatment worked

SEE ALSO:

Immune chemical MS treatment hope
05 Nov 05 | Health

Goat blood drug 'offers MS hope'
21 Mar 05 | Health

Hopes of simple blood test for MS
15 Mar 05 | Health

Multiple sclerosis hormone link
17 Jan 05 | Health

MS damage repair mechanism found
20 Dec 04 | Health

Multiple sclerosis
30 Nov 98 | Medical notes

Q&A: Stem cells
19 May 05 | Health

RELATED INTERNET LINKS:

Ohio State University

Journal of Immunology

MS Society

MS Trust

Multiple Sclerosis Resource Centre

The BBC is not responsible for the content of external internet sites

http://news.bbc.co.uk/1/hi/scotland/4442836.stm

Amanda said the treatment showed almost instant benefits

A young Inverness woman with multiple sclerosis has said she is able to walk for the first time in years only days after revolutionary stem cell therapy.

Amanda Bryson paid £12,000 for a course of injections in the Netherlands, which she believes could cure her.

She has now called on the UK Government to make the treatment available here, but it said more research was needed.

Multiple sclerosis attacks the nervous system, causing loss of balance, reduced vision and localised paralysis.

Ms Bryson was diagnosed with the muscle-wasting disease five years ago and has been almost totally wheelchair-bound.

She read an article about stem cell treatment for her condition, unavailable in the UK, which was being carried out by a US company in Rotterdam.

The process, which she underwent last Friday, only took a few hours.

It just filled me with hope for the future Amanda Bryson

She said: "Within 10 minutes after the treatment I went to the bathroom on my wheelchair, I went to stand up and I thought I was jumping off my chair.

"It felt absolutely fantastic, brilliant.

"I thought at first 'this is in my mind', but I spoke to the nurse who told me it happens, they've seen it happen plenty of times.

"That's the moment where it just filled me with hope for the future."

She added that to date the treatment, using newborn babies' umbilical cords, had not hurt anyone.

She said: "It should be available to patients through their own choice, it's pretty upsetting that it won't be in this country for probably another 20 years."

http://www.newswise.com/articles/view/516122/?sc=rsmn

Libraries Medical News		Keywords COPAXONE, MULTIPLE SCLEROSIS, MS, TEVA
Contact Information Available for logged-in reporters only
Description Clinical research data published in the December issue of Multiple Sclerosis provided evidence that COPAXONE(r) may offer protection from axonal injury and induced neuronal metabolic recovery in patients with relapsing remitting multiple sclerosis.

Newswise — Clinical research data published in the December issue of Multiple Sclerosis provided evidence that COPAXONE® (glatiramer acetate injection) may offer protection from axonal injury and induced neuronal metabolic recovery in patients with relapsing remitting multiple sclerosis (RRMS).

In a pilot study of 18 RRMS patients using brain imaging techniques, COPAXONE® was found to produce significant increases in n-acetylaspartate/creatine (NAA/Cr) ratio, an indicator of neuron and axon integrity, compared to four untreated control patients after one year of treatment. This increase was maintained at two years of follow-up. Additionally, patients treated with COPAXONE® showed a significant 50 percent reduction in relapses compared to baseline (p<0.001)>

“The increases in NAA/Cr ratios with COPAXONE® suggested sustained beneficial effects on cerebral axonal recovery. We believe this indicates a potential for improved electrical conduction pathways in the brain, supporting the emerging concept that, centrally, COPAXONE® may be acting as a neuroprotective agent,” said Omar Khan, M.D., associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University. “This data is of critical significance because axonal transection is a well-known feature of active MS lesions and represents an irreversible stage of the disease process,” said Dr. Khan.

Twenty-two treatment-naïve RRMS patients were included in the study. Baseline neurological assessments and magnetic resonance spectroscopy imaging (MRSI) scans were performed. Eighteen patients were treated with COPAXONE® (glatiramer acetate injection) and followed for two years with neurological assessments every six months and MRSI scans annually. Due to needle phobia, four patients elected to remain untreated and were followed using the same assessment and MRSI schedule. NAA/Cr ratio measurements were obtained in a selected volume of interest (VOI) within the brain and included normal-appearing white matter (NAWM) within the VOI.

In the COPAXONE® group, the NAA/Cr levels within the VOI were significantly increased by 9.1 percent at year one and by 10.7 percent at year two, compared to baseline (p=0.03 for both assessments). Conversely, in the untreated group, a 5.5 percent decrease in NAA/Cr levels was observed in the VOI at year one (p=0.04) and an 8.9 percent decrease at year two (p=0.03). COPAXONE® patients also demonstrated a 5.4 percent and 7.1 percent increase in NAA/Cr ratios within the NAWM at years one and two, respectively (p=0.04 for both). Untreated patients had a two percent (p=n.s.) and 8.2 percent (p=0.03) decrease in NAA/Cr ratios within the NAWM at year one and two, respectively.

“We recognize our study contains limitations, such as the number of patients,
open-label design, and the MRS technique of evaluating NAA levels,” stated Dr. Khan. “However, our recently presented three-year data showed sustained improvements in NAA/Cr ratios which clearly demonstrated a long-term clinical benefit and showed that COPAXONE® treatment may lead to neuronal recovery,” said Dr. Khan.

About COPAXONE®
Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing remitting multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90 percent of Teva’s sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva’s innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva Pharmaceuticals USA and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE®. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
See additional important information at http://www.copaxone.com/pi/index.html or call 1 800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the beliefs and expectations of Teva’s management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the Ivax acquisition, Teva's ability to rapidly integrate Ivax's operations and achieve expected synergies, Teva’s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic version of Neurontin®, the effects of competition on Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva’s ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

10/31/2005 5:00:00 AM EST

PharmaFrontiers Corp. (OTCBB: PFTR), a company involved in the development and commercialization of cell therapies, announced today that the protocol for its Phase IIb clinical trial of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis (MS), has been accepted by the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).

"PharmaFrontiers is very excited to receive a 'green light' from the FDA for our Phase IIb clinical trial. Our earlier open-label Phase I/II clinical trials not only gave us the safety and tolerability data we sought, but we also observed a trend towards a reduction in annualized relapse rate (ARR) in excess of 90%, the lowering of the myelin-peptide reactive T cells (MRTCs) in patients blood and the improvement in patients' clinical measures," said David B. McWilliams, chief executive officer of PharmaFrontiers. "The Tovaxin clinical program continues to show promising results and we believe that the completion of this Phase IIb clinical trial will allow us to launch a Phase III pivotal trial."

Tovaxin is a trivalent formulation of attenuated MRTCs, which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells. MRTCs are believed to play a critical role in the pathogenesis of MS. Because several myelin antigens are described as potential autoantigens for MS, depletion of MRTCs using a trivalent formulation may have enhanced therapeutic effects.

This multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study is designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell therapy with clinically isolated syndrome (CIS) and early relapsing-remitting MS (RR-MS) patients. Additionally, the study of these patients will evaluate biomarkers of Tovaxin's efficacy and to evaluate the effect of Tovaxin on immune deviation and epitope spreading.

"We believe that the protocol design will allow us to study the clinical effects of Tovaxin in a group of patients requiring a safe and effective therapy," said Edward J. Fox, M.D., Ph. D., director of The MS Clinic of Central Texas (Austin) and the lead principal investigator for the upcoming clinical studies. "During this two-arm, 52-week, parallel-group study, patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate. Of the 150 patients participating in the trial, 100 will receive Tovaxin and 50 will receive the placebo."

All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. The open-label study is being planned under a different protocol that will be submitted to the FDA.

"A patient-specific therapeutic vaccination strategy, Tovaxin T cell vaccine is formulated using the MS patient's own myelin peptide-specific activated T cell lines, which are harvested and attenuated on the day of vaccine administration," said Jim C. Williams, Ph.D., PharmaFrontiers chief operating officer. "The shelf-life of the final product is approximately three days."

PharmaFrontiers will be conducting the Phase IIb with its clinical development partner, INC Research, Raleigh, NC.

About PharmaFrontiers Corp.

PharmaFrontiers' strategy is to develop and commercialize cell therapies to treat several major disease areas such as cardiac and pancreatic conditions and Multiple Sclerosis. PharmaFrontiers owns patented and proprietary individualized cell therapies that are in FDA Phase I/II human dose ranging clinical trials to evaluate their safety and effectiveness in treating MS. The company also holds the exclusive worldwide license from the University of Chicago, through its prime contractor relationship with Argonne National Laboratory, for patents relating to the use of adult pluripotent stem cells derived from patients' own circulating blood.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about PharmaFrontiers' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to PharmaFrontiers' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause PharmaFrontiers' actual results to be materially different from any future results expressed or implied by such forward-looking statements. PharmaFrontiers undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

PharmaFrontiers Corp. C. William Rouse, 281-775-0608 brouse@pharmafrontierscorp.com or Investor Relations Contacts: Lippert/Heilshorn & Associates Kim Sutton Golodetz, 212-838-3777 kgolodetz@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com or Media Relations Contact: Mark Stuart, 310-691-7100 mstuart@lhai.com

http://www.genengnews.com/news/bnitem.aspx?name=1092347XSL_NEWSML_TO_NEWSML_WEB.xml

Reported October 26, 2005
http://search.ivanhoe.com/archives/p_archive.cfm?storyid=12364

New Multiple Sclerosis Vaccine

PORTLAND, Ore. (Ivanhoe Broadcast News) -- Multiple sclerosis short-circuits the wiring in the brain, causing loss of feeling, vision problems, fatigue and weakness for about 400,000 Americans. Now a new vaccine is showing promise.

Sue Carlson works up to 12 hours a day helping others feel better. But four years ago, she could barely muster enough energy to work a half day. Multiple sclerosis weakened the entire right side of her body. "I had to move a body part predominantly with my left side and prop it on pillows or towels or blankets in order to do the work I needed to do," she says.

But after six months on an experimental vaccine called NeuroVax, her strength came back. "And it just kept getting better and better and better."

NeuroVax works by increasing the number of disease-fighting white blood cells in the immune system. It did that for all 40 patients who received it. Unlike standard treatments, which have to be given daily or weekly, the vaccine only has to be given once a month, and it doesn’t cause flu-like side effects.

"What patients want are treatments that are not only effective, but also aren't not impacting their quality of life because of side effects," Neurologist Dennis Bourdette, M.D., of Oregon Health & Science University in Portland, tells Ivanhoe.

Researchers say the results are encouraging, but larger studies are needed before it can be approved.

Neurologist Arthur Vandenbark, Ph.D., also of Oregon Health & Science University and Portland V.A. Medical Center, says, "We still have to have a large enough trial that goes on for a minimum of two years where we see a difference between the vaccinated patients and the control group or the placebo group."

After a year without an injection, Carlson is waiting for a new trial to begin, hoping that another dose of the vaccine will give her even more strength.

Patients say the only side effect of the vaccine is a sore arm.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

If you would like more information, please contact:

Multiple Sclerosis Center of Oregon at OHSU
3181 S.W. Sam Jackson Park Road
Portland, OR 97239-3098
(503) 494-5759
msnews@ohsu.edu
http://www.ohsu.edu/ms

http://www.wqad.com/Global/story.asp?S=3989502

Multiple Sclerosis short-circuits the wiring in the brain, causing loss of feeling, vision problems, fatigue and weakness.

About 400-thousand Americans have MS.

Medical Breakthrough has a new vaccine that's showing promise.

"So you smashed your shin when?" Sue Carlson asks a patient.

She works up to 12 hours a day helping others feel better as a massage therapist.

"There's nothing I can't do," she says.

But four years ago, Sue could barely muster enough energy to work a half day. Multiple Sclerosis weakened the entire right side of her body.

"I had to move a body part predominately with my left side and prop it up on pillows or towels or blankets in order to do the work I needed to do," says Sue.

But after six months on an experimental vaccine called Neurovax, her strength came back.

"And it just kept getting better and better and better," she says.

Neurovax works by increasing the number of disease-fighting white blood cells in the immune system. It did that for all 40-patients who received it.

Unlike standard treatments, which have to be given daily or weekly, the vaccine only has to be given once a month, and it doesn't cause flu-like side effects.

"What patients want are treatments that are not only effective, but also aren't not impacting their quality of life because of side effects," says neurologist Dr. Dennis Bourdette.

Researchers say the results are encouraging, but larger studies are needed before it can be approved.

"We still have to have a large enough trial that goes on for a minimum of two years where we see a difference between the vaccinated patients and the control group or the placebo group," says Dr. Arthur Vandenbark.

After a year without an injection, Sue is waiting for a new trial to begin, hoping that another dose of the vaccine will give her even more strength.

Patients say the only side effect of the vaccine is a sore arm.

Both doctors work out of the Oregon Health and Science University/Portland V.A. Medical Center in Portland, Oregon.

You can get more information by logging on to http://www.ohsu.edu/ms or http://www.ivanhoe.com.

Watch the latest Medical Breakthrough every Monday, Wednesday and Friday on NewsChannel 8 at 5 and every Monday and Wednesday on NewsChannel 8 at 10.

Local & Regional News Full Story >