Cephalon Inc. said Tuesday it filed with the FDA aninvestigational new drug (IND) application and a Phase II trialapplication for Myotrophin, its insulin-like growth factor, intreating ALS.
Amyotrophic lateral sclerosis, also known as Lou Gehrig'sdisease, is a fatal disorder characterized by a progressivedegeneration of motor neurons. Death typically occurs three tofive years after onset of the disease as a result of respiratoryfailure. The disease affects about 25,000 Americans.
A Phase I trials in of Myotrophin started in April. Preclinicalstudies indicated that Myotrophin stimulates the growth andenhances the survival of spinal cord motor neurons, accordingto Cephalon. The protein, naturally found in muscle, is suppliedto Cephalon by Sibia Inc.
Cephalon (NASDAQ:CEPH) was granted in June a U.S. patent foruse of Myotrophin in certain central nervous system disorders,including ALS. Myotrophin has also received orphan drugdesignation to treat the disorder.
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