Cephalon Inc. said Monday that it completed its North AmericanPhase I/II trial of Myotrophin for the treatment of amyotrophic lateralsclerosis (ALS), or Lou Gehrig's disease.
Results will be analyzed soon and aren't expected to be released untilan ALS conference in France on June 8-10. It is the first study ofMyotrophin, or recombinant human insulin-like growth factor (IGF-1), that will capture efficacy data.
A similar Phase II/III trial ongoing in Europe is expected to becompleted this summer. A Cephalon spokesman said it's not yet clearwhether both studies will be needed for a submission to the FDA formarketing approval.
"It's conceivable [with positive results] we would be in a position tofile for approval at the end of 1995 or early in 1996," Jason Rubin,vice president, corporate communications for the West Chester, Pa.,company, told BioWorld.
The Phase II/III study involved 266 patients in a double-blind,placebo-controlled trial at eight centers. Myotrophin is beingdeveloped in the U.S. and Europe in collaboration with Chiron Corp.,of Emeryville, Calif.
Rubin said a safety review, conducted in November by anindependent review board, resulted in no concerns for the first 100patients in the trial. "That was not a surprising finding, given theevidence to date, but nonetheless it was a welcome conclusion froman independent review board."
The trial had two drug arms and one placebo. Results will bemeasured by an Appel ALS rating score, which measuresneuromuscular strength and function.
Cephalon already has a sales staff of about 30 calling on neurologistsin the U.S. That was built after an alliance was formed last yearallowing Cephalon to co-promote Bristol-Myers Squibb Co.'s StadolNS nasal spray, an opioid analgesic. Cephalon has another product,modafinil, in Phase III trials for narcolepsy.
Cephalon's stock (NASDAQ:CEPH) closed unchanged Monday at$7 per share. _ Jim Shrine
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