MS Forum Site of information

nani · Posted: Mon Nov 07, 2005 2:50 am Post subject: news

Dr Brian Styeingo is running this trial down here....Penny
Experimental MS Drug Moves Forward in Clinical Trials

by John C. Martin
Article Date: 10-21-05

An experimental medication designed as a therapy for people with relapsing multiple sclerosis (MS) is continuing to show promise. The drug, known only by its code name, FTY720, and manufactured by Novartis, demonstrated positive results in a Phase 2 trial, whose findings were released at a medical conference overseas earlier this month.1

'Excited' by Positive Findings
The findings were part of an extension of the trial, held over the course of a year, to test the oral medication. Patients in the study had been taking one of two doses of the drug, either 1.25 milligrams (mg) or 5 mg. The investigators found that those taking the drug versus a non-therapeutic intervention known as a placebo had at least a 50% reduction in their relapses by the first six months of the extension. The researchers reported these patients continued to maintain low relapse rates for the remaining six months.

When magnetic resonance imaging (MRI) tests were taken, more than 80 percent of the patients who had taken the drug had no brain lesions, which would normally show up in parts of the brain where inflammation had occurred. This was true, regardless of the dose of the drug taken.

"We are excited by these full-year study results confirming the significant effect of oral FTY720 on reducing both clinical relapses and inflammatory disease activity that we first saw during the first six-month placebo controlled phase of the study," explained Ludwig Kappos, MD, in the department of Neurology at the University of Basel in Switzerland, the study's leader. "We hope that the magnitude of benefits shown in Phase 2 will be confirmed in the larger scale phase 3 study program expected to be launched soon."

Clinical trials are conducted in three phases, the third of which is the typically the pivotal study, whose results are submitted to regulatory authorities such as the FDA in hopes of receiving approval to market the medication under investigation.

The phase 3 trial is expected to be launched at the end of 2005, according to Novartis.

Re-Routing Inflammation-Causing Cells
FTY720 works by helping to redirect lymphocytes (white blood cells) away from blood and targeted organs like the central nervous system, thereby reducing inflammation. It's believed MS may be an autoimmune attack, in which the immune system (which includes white blood cells) mistakenly attacks tissue in the central nervous system, resulting in damage and the symptoms manifested in the disease.2

In the phase 2 extension study, nearly 300 patients at 32 centers in eleven countries took part. The patients were selected at random to receive either two doses of FTY720 or a placebo once per day for six months. The study evaluated the effect of the drug on disease activity, measured by taking regular MRI readings, as well as evidence of clinical relapses and safety and tolerability. After six months, those assigned to the group given regular placebo doses were selected again at random to receive either 1.25 mg or 5 mg of FTY720 for an additional six months. Those already on the drug for the initial phase continued that regimen for the remainder of the trial. Both studies were blinded, meaning neither clinical staff nor patients knew whether they were taking the drug or placebo, nor which dose of either.

'Promising Data'
At the end of the trial, both groups of patients taking doses of the medication experienced only about half of their original number of relapses, on average, during the first six moths compared to those who were on a placebo, the investigators reported. They maintained this lower relapse rate until the end of the study. Additionally, those who switched from placebo to either dose of FTY720 after the first six months had an average 70% reduction in the number of relapses, the study investigators reported.

MRI results after the 12-month trial showed an average reduction of more than 80% in the number of inflammatory lesions in those who had switched from taking a placebo to the medication, compared to the number of lesions they had at the 6-month point in the trial.

More than 80 percent of patients who received FTY720 had no evidence of active inflammation by the 12th month of treatment regardless of the dose of the drug taken.

The drug also appeared to be well tolerated, with most patients who entered the extension phase completing the 12-month study. There were no unexpected side effects in the extension phase compared to the 6-month placebo-controlled phase. The most frequent side effects reported were colds, influenza, headache, diarrhea, and nausea.

"If these promising data are confirmed in phase 3, FTY720 might represent a new potent therapeutic option in MS with the additional benefit of oral administration," wrote Kappos and his trial colleagues.

1. 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis. 2005 Sep 28-Oct 1. Thessaloniki, Greece.
2. National Multiple Sclerosis Society. What is Multiple Sclerosis? Available at: http://www.nationalmssociety.org/What%20is%20MS.asp. Accessed October 7, 2005.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
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Welcome to my info site, as I call it. I have Multiple Sclerosis in secondary progression stage. I post what I find useful and hope you can help out with a donation of $1 if you can. If not it's ok... thanks Nani