Synta will resume studies of skin cancer drug

Tue, 03/02/2010 - 3:17am
The Associated Press

Synta Pharmaceuticals Corp. said Tuesday it will restart development of its skin cancer drug candidate elesclomol.

Synta said it expects to start at least one new clinical trial in the second half of 2010. The company said it reached its decision after consulting with the Food and Drug Administration. Research on elesclomol in skin cancer was stopped in February 2009 because of unexpected numbers of deaths among test subjects who took the drug.

The company later said elesclomol did not meet its goal in the trial. Elesclomol is being developed to treat melanoma that has metastasized.

Synta said the new studies will exclude patients with a high level of lactate dehydrogenase, or LDH, an enzyme that is linked to melanoma. Earlier research shows that elesclomol helped extend the lives of patients with normal LDH levels but did not work as well on patients with high LDH levels.

The company said patients with high LDH have lower oxygen levels, which changes the metabolism of cancer cells and reduces the effectiveness of elesclomol. In patients with normal LDH levels, study data show a combination of elesclomol and the chemotherapy drug paclitaxel was significantly more effective than paclitaxel alone, Synta said.

The FDA would have to approve other clinical trial designs, the company said. It plans to provide more details on its plans over the next few months.


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