Regeneron Pharmaceuticals Inc. said Tuesday that it has beguna Phase III study to determine the safety and efficacy of itsrecombinant human ciliary neurotrophic factor (rhCNTF) totreat amyotrophic lateral sclerosis (ALS, or Lou Gehrig'sdisease).
The double-blind, placebo-controlled study, scheduled to beginthis week, will include two dose levels of rhCNTF and willinvolve more than 700 patients in more than 30 clinical sites inthe U.S., according to Regeneron (NASDAQ:REGN) of Tarrytown,N.Y.
The trial will investigate the safety of rhCNTF, as well as itsability to slow the rate of progression of the disease, thecompany said. If the study is successful, Regeneron said it willuse the data to support a product license application (PLA) toFDA.
ALS is a disease of the motor neurons, the nerve cells thatcontract muscles. Degeneration of the nerve cells causes muscleweakness and, invariably, death.
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