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Genta Drug Extends Life by a Month in Skin Cancer Study

The company calls the results 'promising' and say they back up an FDA filing.
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Skin cancer patients taking chemotherapy plus a drug developed by






lived about a month longer in a clinical study than patients who didn't get the drug, the companies said Wednesday.

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The study looked at 771 malignant melanoma patients already on chemo, some of whom were given an additional dose of the Genta/Aventis drug, Genasense. People in the latter group survived an average of 9.1 months, compared with 7.9 months with patients who only got chemo. The difference was similar in patients who completed a 12-month followup.

The companies didn't make any qualitative assessment of the results' significance in the press release announcing them, although they did say the data supported the new drug application it began under the FDA's fast-track designation. Genta's heavily shorted stock wasn't doing anything in premarket trading.

"One of our primary goals at Aventis is to deliver innovative products that help patients with cancer live longer with a better quality of life," the company said. "Today's promising data may lead to an important advance in targeted therapies for patients with advanced malignant melanoma."



subscription sister site, columnist Adam Feuerstein said a metric that measures the possibility of statistical noise in the study indicated an 18% chance the difference between the two patient classes was random. Normally the upper threshold for the possible interference of randomness is 5%, he noted.