Fingolimod (which, by the way, wins our award for Most Unintentionally Humorous Drug Name) works by keeping the immune system's T cells in the lymph nodes and away from the central nervous system, which is for reasons yet unknown, vulnerable to attack in an MS patient.

The trial enrolled over 250 patients. In the first six months, patients were randomized to receive either one of two doses of fingolimod, or a placebo. For the following six months, all the placebo patients were randomized to one of the two fingolimod doses.

The results...

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The results showed that patients taking FTY720 who had originally experienced a reduction in their annualized relapse rate of more than 50% during the first six months of the trial maintained this reduction in the following six months of therapy. In other words, for people who saw benefit in the first six months of therapy, the drug continued to work.

Interestingly, those patients who were originally on placebo during the first six months of the trial and then switched to FTY720 during the latter 6 months showed a 70% reduction in annualized relapse rate.

Finally, greater than 80% of patients on FTY720 for the full 12 months were found to be free from active lesions on their MRIs at the end of the trial.

As we know, a reduction in relapses does not necessarily equate a reduction in disability progression, but it is of course a welcome step demonstrated by this promising data.

Novartis plans to begin Phase III testing by the end of the year, pending FDA approval. If you recall, FTY720 trials were halted after the Tysabri suspension, with the FDA asking Novartis for more information on FTY720's usage in transplant patients prior to continuation.

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While the drug has just passed Phase II and thus has a few years ahead of it in Phase III trials, it is clear from the three candidates mentioned above that daily or weekly injectable medications should one day be a distant memory for MS'ers. The final Phase III trials are slated to start in a few months:

"FTY720, an oral immunomodulator with a novel mechanism of action, has shown excellent efficacy in multiple sclerosis (MS) in a Phase II study. FTY720 has the potential to become the first efficacious oral therapy for MS, a condition estimated to affect more than one million people worldwide. Data from the Phase II study showed a significant reduction in the relapse rate and in the number of brain lesions detected by MRI scan as well as a longer time to first relapse. The vast majority of patients are continuing in the extension phase. One-year data are expected in mid-2005. Phase III studies are planned to start in mid-2005."

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