The Phase II/III clinical trials of Synergen Inc.'s ciliaryneurotrophic factor (CNTF) for treating Lou Gehrig's disease(amyotrophic lateral sclerosis, or ALS) are under way.
The Syntex-Synergen neuroscience joint venture, formed in1990 to develop CNTF and other neurotrophic factors,announced Thursday that the drug treatment portion of thePhase II/III safety and efficacy trial began in early August.
Patient recruitment for the multicenter, double-blind, placebo-controlled study began in April. Those patients were evaluatedfor three months prior to drug treatment and are currentlyreceiving one of three doses of CNTF or placebo.
The goal of the study is to ascertain whether CNTF, a nerverepair factor, can prevent or slow the degeneration of primarymotor neurons that ultimately leads to death in peoplesuffering from ALS. Patients enrolled in this study are requiredto be in the early course of their disease (less than threeyears). They also must have measurable muscle strength in theupper extremities so that any changes can be measured overthe six-month drug treatment phase of the study.
The trials are still open for enrollment; the companies intend toenroll from 600 to 800 patients overall, explained Paul Laland,associate director of corporate communications at Synergen(NASDAQ:SYGN) of Boulder, Colo.
Synergen and Syntex (NYSE:SYN) of Palo Alto, Calif., initiatedthe Phase I safety and pharmacokinetic trial on CNTF in May1992. That trial was completed last January and the data willbe presented at the American Neurological Society meeting inBoston in October, Laland told BioWorld.
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) of Tarrytown,N.Y., is also developing CNTF for treating ALS. Regeneron beganits Phase III trials in late March and reported Phase II dataearly this month. They indicated that CNTF is safe and well-tolerated, but did not slow rates of disease progression to astatistically significant level.
And Regeneron, through its partnership with Amgen Inc.(NASDAQ:AMGN), is ready to test a second neurotrophic factor,brain derived neurotrophic factor (BDNF), against ALS. Amgenfiled the investigational new drug (IND) application on July 19.
Also working on a cure for ALS is Cephalon Inc.(NASDAQ:CEPH), which is testing its recombinant insulin-likegrowth factor (IGF-1) in Phase II/III clinicals.
Synergen's stock gained 13 cents a share to close Thursday at$10.50; Syntex's stock gained $1.25 a share, closing at $18.38.
-- Jennifer Van Brunt Senior Editor
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