Genta Melanoma Drug Study Disappoints: BioBuzz

Genasense year-end FDA filing now delayed.
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) -- The resurrection of



doesn't appear to have a happy ending.

The drug maker reported results Thursday from its latest phase III study of Genasense in melanoma and the data aren't encouraging.

Treatment with Genasense failed to demonstrate a statistically significant improvement in progression-free survival -- a co-primary endpoint of the study. Secondary endpoints of the study, including response rate and overall disease control rate, also failed to show a benefit favoring Genasense.

The only positive thing Genta had to say about the Genasense study was that the drug cleared a futility test for overall survival -- the other co-primary endpoint. But Genta said it was still too early to determine whether Genasense patients lived longer than those in the study's control arm.

Plans to seek Food and Drug Administration approval for Genasense in melanoma before the end of the year have now been put on hold given these results, said Genta CEO Ray Warrell.

Detailed data from the study will be presented on Nov. 15 at a meeting of cancer researchers in Boston.

In 2004, the FDA rejected Genta's application for Genasense in melanoma on the basis of a previous phase III study that also failed to demonstrate a survival benefit favoring the drug.

For this latest phase III study, Genta limited enrollment to a subset of melanoma patients with low levels of LDH, a blood enzyme, who appeared to live longer after treatment with Genasense during the first study. Conversely, patients with elevated levels of LDH were not helped at all by Genasense.

Safety Issues Delay Transcept Sleep Drug Approval

The FDA wants more safety data from

Transcept Pharmaceuticals


before approving the company's insomnia drug, the company said Thursday.

Transcept was seeking FDA approval for Intermezzo as a sleep aid for people who wake up in the middle of the night but can't fall back to sleep. The drug's active ingredient is a low dose of the popular sleeping pill Ambien formulated into a tablet that dissolves quickly in the mouth.

But the FDA said it was not comfortable with Intermezzo's safety profile, particularly the risk that people might suffer lingering effects from the drug after they woke up. In particular, regulators want Transcept to show that Intermezzo has no negative effect on next-day driving ability, the company said.

Transcept said it may have to conduct one or more additional safety studies to provide FDA with the data it needs to approve Intermezzo.

Transcept shares closed Wednesday at $11.47 but appear to be trading sharply lower in pre-market trading Thursday.

-- Reported by Adam Feuerstein in Boston

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