The race for an oral multiple sclerosis medication took one further step today, when Teva and Active Biotech announced that they were going to begin the final Phase of clinical testing for their pill candidate, called laquinimod.

This followed the successful conclusion of Phase II, as well as consultations with the US FDA. Drugmakers are cautious...

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A new Phase IIb study has launched, intending to enroll 150 relapsing-remitting multiple sclerosis patients in a multicenter, placebo-controlled trial. It is a year-long study, where the medication is given (by subcutaneous injection) 5 times, at inception, then month 1, 2, 3 and 6. The primary endpoint is, as typical, the number of T1 enhancing (and thus active) lesions on MRI at various weeks after the final injection. Secondary endpoints include...

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In what at first seems like a contradiction, Teva, manufacturer of the multiple sclerosis treatment Copaxone, is now enrolling for a large trial examining so-called Neutralizing Antibodies (NAbs) to high-dose Interferon-beta. Copaxone, or glatiramer acetate, is notable for being the only mainline therapy that is not an interferon (excluding for the time being Tysabri and Novantrone).

NAbs, when present, have been shown to negatively affect the therapeutic value of the interferon drugs, developing in somewhere between 5-45% of patients receiving interferon treatments like Avonex, Betaseron and Rebif. Teva contends that though the impact of the NAbs is gigantic, testing for their presence is not routine.

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We have heard rumors from trial participants that Antegren will be renamed "Tysabri" to resolve a conflict with another, already-approved drug. We verified that Elan does indeed own "tysabri.com," so there seems to be some merit in it...

Well, we will remain dedicated to being your source for unbiased information on Tysabri or Antegren or natalizumab or whatever have you. Quite frankly, they can call it "dirt," and as long as it helps our community, we will not care.

But Tysabri... could this be any harder to pronounce and/or spell? :)

This is a good article summarizing some of the most current research from the perspective of 3 well known members of the MS community...

"Until about a decade ago, a list of any year's advances in multiple sclerosis research would be pretty scant. But since the introduction of the first drug therapies for MS -- which transformed it from an untreatable to a treatable disease -- MS research has burgeoned. During the past year alone, so many intriguing developments have been announced that it's hard to keep them straight. It's even harder to keep them in perspective.

MS experts don't always agree on what is most newsworthy, though their assessments often overlap. Three such experts -- Henry McFarland, the National Institutes of Health's top MS doctor, Stephen Reingold, vice president for research programs at the National MS Society, and Art Mellor, who founded the Boston Cure Project after being diagnosed with MS in 2000 -- helped compile this list of the past year's key developments..."

Click "read more" for the full article...

Bayer is researching IGIV as a treatment for MS. Note that a few studies have already been done showing that this is an effective treatment, but the dosage (and efficacy) is to be determined in this trial. Note that, like Antegren, this is a monthly IV-- hope for an end to frequent pinpricks is in sight...

"Bayer HealthCare LLC, Biological Products Division (Bayer BP), has closed enrollment in the first industry-sponsored trial to evaluate immune globulin intravenous (IGIV) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under an Investigational New Drug application (IND) submitted to the U.S. Food and Drug Administration (FDA), the multi-national clinical trial will assess the efficacy and safety of Gamunex®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, in RRMS.

Other data in this field, including published studies, point to IGIV as potentially effective in the treatment of RRMS. Most recently, a retrospective analysis of 300 patient medical records conducted in Germany and Austria documented use of IGIV in the treatment of RRMS. The analysis showed IGIV significantly reduced the annual relapse rate by 69 percent compared with the two years prior without IGIV treatment. In addition, a meta-analysis of four randomized, placebo-controlled trials of IGIV in patients with RRMS conducted in Europe and published in the journal Neurological Sciences in 2003 showed positive results for primary endpoints, including relapse rate, new MRI lesions, and disease progression. The author concluded IGIV is an alternative second-line treatment to approved therapies in relapsing-remitting MS, but the ideal dosage of IGIV still needs to be determined..."

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www.gamunex.com www.plasbumin.com www.prolastin.com www.talecrisusa.com www.talecrisdirect.com"

This study examines the 5 available drugs (the CRABs + Novantrone), noting where in the disease progress they are effective. It also discusses the negative side effects of each and how they are being improved upon in future therapies.

"The approval by the FDA of four immunomodulators (three IFNs and glatiramer acetate) and one immunosuppressant (mitoxantrone; Novantrone) for the treatment of multiple sclerosis is definitely the most important progress in this field since the first description of the disease > 150 years ago. However, both types of immunotherapies raise specific problems...

Combination therapies with immunomodulators and antioxidants or with neuroprotective drugs against excitotoxicity or Na + /Ca 2+ channellopathy are currently being investigated. With regard to immunosuppressants, the development of monoclonal antibodies with fully human protein sequences and the synthesis of a new molecule as effective as mitoxantrone but with a much lower toxicity (pixantrone) seem promising to halt or even to prevent disability progression."

Click "read more" for the full abstract... we cannot post the entire article because it requires a subscription to the original journal.

When the Body Attacks Itself

Autoimmunity: Rates of immune disorders like Crohn’s and MS more than doubled in 40 years

"The immune system is a thing of beauty—subtle enough to distinguish dangerous invaders like viruses from benign interlopers such as food; clever enough to recognize when the body’s supposedly friendly cells turn cancerous and should be eliminated. But the immune system can also go seriously awry. When it begins mauling healthy tissues, the result can be any one of 80 autoimmune diseases such as lupus or rheumatoid arthritis. “It’s the price we pay for having such a dynamic, finely balanced system,” says immunobiologist Jeffrey Bluestone, director of the Immune Tolerance Network at the University of California, San Francisco."