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Biotech / Medical : Genta, Inc. (GNTA) -- Ignore unavailable to you. Want to Upgrade?

To: tommtn who wrote (1778)	4/30/2004 12:14:14 PM
From: Jim Oravetz	Respond to of 1870

Genta Dn 37%; FDA Issues Briefing On Cancer Drug Genasense DOW JONES NEWSWIRES April 30, 2004 11:03 a.m. By Roger Cheng Of DOW JONES NEWSWIRES NEW YORK -- Two pharmaceutical companies lost nearly half their stock values Friday amid the rising possibility both companies' cancer drug candidates could face regulatory hurdles. Genta Inc. (GNTA) shares plunged more than 43% Friday after the Food and Drug Administration issued a briefing on the biotech's cancer drug Genasense that was less positive than expected. Meanwhile, Allos Therapeutics (ALTH) fell more than 40% Friday after a Schwab Soundview analyst said the FDA is unlikely to approve Allos' drug, RSR13, for treating brain metastases in breast-cancer patients. Both companies' treatments are slated to undergo review with the FDA's Oncologics Drug Advisory Committee Monday. Given their respective clinical setbacks, an approval isn't a guarantee. An FDA briefing on Genta's Genasense, while still showing some benefit in its secondary targets, also indicated it wasn't able to show a significant advantage in its primary survival goal, according to Delafield Hambrecht analyst Quynh Pham. Genasense, which is being co developed by Aventis S.A. (AVE), is supposed to work in combination with dacarbazine and is being tested on patients with advanced melanoma who have received no prior chemotherapy. The tests determine whether there is a statistical advantage of Genasense and dacarbazine versus just dacarbazine alone. Most disappointing was Genasense's primary endpoint of the overall survival rate, which was "statistically insignificant" in efficacy, according to the FDA briefing. Results, however, did favor the group using both treatments. Genasense is slated to undergo review by the Oncologics Drug Advisory Committee on Monday, and, while the positive secondary endpoints may be enough to warrant a positive review, it's still an uncertainty. "(Genta's) case isn't as strong as it was yesterday," Pham said, adding the panel will likely scrutinize the data even more. A spokesman for Genta wasn't immediately available for comment. Genta recently traded at $8.52, down $5.88, or 40.7%, on volume of 18.5 million shares. Average daily volume is 1.4 million shares.