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Genta's Genasense Still a Long Shot

SAN DIEGO -- Genta (GNTA) may seek a second shot at marketing approval for its experimental cancer drug Genasense, but don't expect things to turn out any better than the first time.

Still, some investors seemed eager to take a flier on Genta's chances at resurrection. The stock closed up 67 cents, or 48%, to $2.05 on Monday. But that was down from its intraday high of $2.40, or up 74%, reached before a presentation on a form of leukemia at 2:15 p.m. EDT. More than 62 million shares traded hands in a company with a 73 million-share float and a 30-day daily average volume of 2.9 million shares.

At an oral presentation at the American Society of Hematology meeting Monday, the Berkeley Heights, N.J.-based drugmaker said the addition of Genasense to chemotherapy increased "major" responses in patients with advanced chronic lymphocytic leukemia (CLL) in a phase III study.

But this increase in response had no clinically meaningful effect on patients in terms of increasing their survival or even delaying the progression of disease. And the Genasense-chemotherapy combination used in the study is relatively outdated, with newer drugs, including Genentech's (DNA) Rituxan, producing better responses in similar CLL patients.

During Monday's presentation, the Genasense study's lead investigator, Dr. Kanti Rai of Long Island Jewish Medical Center, did not specifically endorse a Food and Drug Administration filing based on this clinical data. While he believes in the promise of Genasense in CLL, Rai said different dosing schedules and/or studies of the drug in newly diagnosed (read: less sick) CLL patients is needed.

Genta has not yet said publicly whether it will seek FDA approval for Genasense in CLL, but the down-and-out company has little to lose. In May, Genasense was rejected by an FDA advisory panel as a melanoma treatment, sending shares tumbling into the single digits. At present, Genta has lost its corporate partner, Aventis (AVE), and is running short of cash. A separate phase III study in multiple myeloma, also presented over the weekend at the ASH meeting, was a failure.
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