Probably should add Alemtuzumab to the name of this sub-forum as that seems to be the name for the drug as used in the MS trials.
Here is some more info:
GENZ Genzyme : Study results have shown that Multiple Sclerosis patients have significant and sustained reduction in disability and risk of relapse on Alemtuzumab versus active comparative drug (66.11 -2.21) -Update-
Co Genzyme Corporation (GENZ) and Bayer HealthCare Pharmaceuticals announced study results showing that patients with early relapsing-remitting multiple sclerosis (RRMS) taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 74% and the risk of sustained accumulation of disability by 71% compared to patients treated with the active comparator Rebif (high-dose interferon beta-1a). Importantly, the mean disability of patients on alemtuzumab improved from baseline, whereas the mean disability of those on Rebif worsened. The treatment benefits of alemtuzumab were sustained for at least three years, even though the majority of alemtuzumab-treated patients were last dosed two years earlier. These results come from the final three-year analysis of a Phase 2 clinical study (CAMMS223) reported in the Oct. 23 issue of the New England Journal of Medicine. The study involved 334 patients who had not previously been treated for their disease. "The alemtuzumab trial data continue to suggest a potentially new and exciting treatment for patients with early, active multiple sclerosis," says Alastair Compston, Professor of Neurology and the head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom, and the study's principal investigator. "This randomized study confirms findings from prior studies demonstrating that treatment with alemtuzumab can have a profound and durable impact on patients with relapsing-remitting multiple sclerosis, including restoring some lost function in many patients... The trial was larger and follow-up was longer than the typical Phase 2 trial in multiple sclerosis. It is important to note that we compared the investigative drug directly against a widely used therapy rather than against placebo. The trial did not show an increased risk of life-threatening or opportunistic infections, but a proportion of alemtuzumab patients experienced new autoimmune disease. We have been able to create a robust patient monitoring program that allows us to proceed into our two international Phase 3 trials with greater assurance on safety associated with patient management," says Dr. Richard Moscicki, chief medical officer for Genzyme.
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Doctors yesterday hailed a major success in the treatment of multiple sclerosis, after trials revealed that a drug had halted and reversed the debilitating effects of the disease for the first time.
The unprecedented results will boost the hopes of thousands of people in Britain in the early stages of the condition, which destroys the central nervous system.
Existing medications, such as beta interferon, at best slow the disease, which causes the immune system mistakenly to attack fatty coatings around nerves that are needed to make sure signals are passed down them properly.
Doctors at Cambridge University led a three-year trial of the drug, alemtuzumab, to compare its effectiveness against the market-leading beta interferon treatment. They recruited 334 patients with MS in their 20s and 30s, all of whom had experienced their first symptoms no more than three years ago.
Patients who were given the new drug were 74% less likely to relapse and had a 71% lower risk of being disabled within three years. But most remarkably, those on the new treatment showed fewer signs of disability at the end of the trial than they began with.
The drug is a synthetic antibody that was developed at Cambridge 30 years ago as a treatment for leukaemia. While it is now licensed as a treatment for chronic leukaemia, scientists suspected it might also benefit MS patients because it dampens down the immune system.
"For the first time we've shown definitely that treating people early on with this aggressive immunosuppression is a good thing and we can say people's disability improves. That's never been seen before and goes counter to everything we thought," said Alasdair Coles, a member of the Cambridge team, whose study appears in the New England Journal of Medicine.
"What is unprecedented and fascinating is that patients who take beta interferon have slowly shrinking brains as the disease attacks their brain tissue. We used MRI scans to show that patients who have alemtuzumab have enlarging brains as the lost tissue is restored. Somehow the drug is promoting brain repair," Coles added.
In the trial, patients were given either a beta interferon injection three times a week for a year, or five days of alemtuzumab infusions followed by a three-day follow-up treatment a year later. The drug is now in a phase three clinical trial, which will be used to work out the best dosages. If the trial is a success, it could be licensed as early as 2010. For the drug to be approved, licensing bodies will have to be convinced that it can be used safely, but two major side-effects have been identified.
When the drug is given, it appears to suppress the immune system by reducing white blood cells called lymphocytes, which are crucial for the body to fight infections. Although the patients in the trial did not suffer from a rise in infections, some did develop new immune disorders. The most common side-effect involved the immune system attacking the thyroid gland, which affected nearly 25% on the new drug. A few patients (2.8%) suffered an immune disorder which affected plate lets in their bloodstream. One patient in the trial died of the condition. "Both of these conditions can be monitored and treated providing diagnosis is made quickly enough," said Coles.
"I'm sure this is the most effective way to treat MS and it's the best we'll see in terms of efficacy," he added. The trial intentionally focused on patients who were in the early stages of the disease. Longer-term patients are not expected to respond as well to the treatment.
Despite the potential for serious side-effects, the trial was lauded as a major step towards treating the disease. In Britain about 100,000 people are affected by multiple sclerosis.
also see:
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WebMD: Guarded Optimism for Experimental MS Drug>
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Boston Herald: Leukemia Drug May Treat MS>
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Google Article>
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BBC UK>
