Cephalon Inc. announced Tuesday that it has initiated EuropeanPhase II/III clinical trials of Myotrophin for treatingamyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease), afatal condition that is characterized by the progressivedegeneration of motor neurons.
Cephalon (NASDAQ:CEPH) of West Chester, Pa., said it plans toenroll about 150 patients in the double-blinded, placebo-controlled trials, which will take place at major ALS clinics inthe United Kingdom, France, Italy, Belgium, Germany and theNetherlands.
The European trial is Cephalon's second Phase II/III on its drugMyotrophin, which consists of recombinant human insulin-likegrowth factor I (IGF-1) that is known to mediate the nervoussystem's recovery from injury. Myotrophin has been shown innumerous animal studies to promote the survival of motorneurons and enhance the regeneration of damaged motornerves.
Cephalon initiated advanced clinical trials in the U.S. in January.
"The Phase II/III European clinical protocol is consistent withthe ongoing U.S. study and involves a three-month baselineevaluation followed by a nine-month dosing regimen," saidFrank Baldino, Cephalon's president and chief executive officer.
Cephalon holds a U.S. patent for the use of Myotrophin incertain neurodegenerative disorders, including ALS. As well,the FDA has awarded orphan drug status to Myotrophin fortreating ALS.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.