Regeneron Pharmaceuticals Inc. announced Wednesday atHambrecht & Quist's 11th Annual Life Sciences Conference inSan Francisco that it has initiated a Phase II clinical trial of itsrecombinant human ciliary neurotrophic factor (rhCNTF) inpatients with Lou Gehrig's disease, or amyotrophic lateralsclerosis (ALS).
The Tarrytown, N.Y, company said it hopes to start a large,pivotal Phase III trial on rhCNTF in the first half of this year,according to Leonard Schliefer, president and chief executiveofficer.
"ALS is a disease for which there is no drug available andwhich is invariably fatal," Schliefer said. "That means it will beon a fast track for approval with FDA."
Regeneron's Phase I study on rhCNTF was unique, Schliefer saidat H&Q, because it was a double-blinded, placebo-controlledtrial. The Phase I trial, completed in the fourth quarter of 1992,involved more than 50 patients and established the short-termsafety and tolerability of rhCNTF. FDA granted this compoundorphan drug status in February 1992.
Schliefer said Regeneron had $82 million in cash on hand at theend of December.
Regeneron's stock (NASDAQ:REGN) was up $1 a share onWednesday to $14.75.
-- Jennifer Van Brunt Senior Editor
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