Sibia Inc., a San Diego area neuropharmaceutical company,announced that it has received clearance from the FDA to beginclinical trials of the anti-epileptic drug SIB-S1 licensed fromthe Belgian company UCB. Privately held Sibia filed itsinvestigational new drug (IND) application in August, andanticipates that it will be able to proceed rapidly through PhaseI studies to pivotal Phase II/III trials based on UCB's clinicalwork in Europe, according to William Comer, Sibia's presidentand chief executive officer.
Sibia entered into an agreement with the pharmaceutical sectorof UCB in January to develop and co-promote SIB-S1 in the U.S.and Canada. Sibia is responsible for the clinical developmentand registration of the drug in these markets and willcoordinate its clinical work with UCB's in Europe.
The compound (which UCB calls ucbL159) is a small organicmolecule. It's undergone extensive preclinical and early clinicaltesting by UCB in Europe. According to Sibia's Comer, "Itappears to be well-tolerated in humans and has demonstratedpromising activity in open-label trials involving patients withvarious types of seizures not controlled by existing drugs."
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.