Cephalon Inc. on Tuesday said it has started Phase I Europeantrials of Myotrophin, its recombinant insulin-like growth factortreatment for amyotrophic lateral sclerosis.
Preclinical studies indicate that Myotrophin IGF-1 stimulatesthe growth of and enhances the survival and/or functioning ofspinal cord motor neurons, said spokeswoman Nicole Vitullo.The protein, normally found in muscle, is supplied to Cephalonby Sibia Inc.
Cephalon hopes to submit Phase I data and an investigationalnew drug application for Phase II studies to the FDA in June,Vitullo said. The West Chester, Pa., company (NASDAQ:CEPH) inMarch received a U.S. patent for use of Myotrophin in certaincentral nervous system disorders, including ALS. Myotrophinalso has received orphan drug designation to treat the disorder,known as Lou Gehrig's disease.
The company hopes to capture about 70 percent of theestimated $150 million to $300 million U.S. market for ALStreatments, Vitullo said.
Cephalon is conducting preclinical studies of Myotrophin as atreatment for a broad class of diseases that involve loss offunction in sensory and motor nerves in the peripheral nervoussystem, such as chemotherapy-induced neuropathy. "We hopeto file an IND to treat these peripheral neuropathies by the endof the year," Vitullo told BioWorld.
Cephalon stock closed down 50 cents Tuesday at $11.
-- Kris Herbst BioWorld Washington Bureau
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