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news.Avigen, a biopharmaceutical company innovating therapeutics for neurological care, has completed double-blind portion of its Phase IIb trial for AV650 in the treatment of spasticity associated with multiple sclerosis.
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This Phase IIb spasticity trial is evaluating the safety, tolerability and efficacy of AV650 in multiple sclerosis (MS) patients at doses up to 900mg/day for one month followed by an open-label safety extension. The trial is being conducted in MS centers in Germany and several other European countries.
Avigen is developing AV650 for commercialization in the North American market for the treatment of disabling neuromuscular spasticity and spasm under a license and supply agreement with Sanochemia Pharmazeutika, Vienna, Austria. AV650 is considered a new chemical entity in the US.
Kenneth Chahine, president and CEO of Avigen, said: “The completion of this trial in less than a year marks a significant milestone for the AV650 program and Avigen. The rapid enrollment further supports the need for new and non-sedating agents to treat spasticity, and we have confidence that our planned Phase III trials can be completed in a similar timeframe.
“While the blinded portion of the trial is complete and will report before the end of 2008, more than 90% of the patients have elected to participate in the on-going open-label extension and will continue to receive AV650 for up to an additional twelve months.”