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"Stunning" Disappointment for Melanoma Drug

By March 1, 2009

Synta Pharmaceuticals has halted a phase III trial after a greater number of people taking their new melanoma drug elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other studies of the drug for other cancers. "This is a stunningly disappointing day for all of us at Synta," said CEO Safi Bahcall, PhD. Added Eric Jacobson, MD, Chief Medical Officer of Synta: "We are enormously disappointed for melanoma patients, particularly because there are so few treatment options available."

The elesclomal SYMMETRY trial enrolled 630 subjects and was designed to compare elesclomol in combination with paclitaxel to paclitaxel alone in patients with stage IV metastatic melanoma. Elesclomol represented a new treatment approach: it was designed to elevate the oxidative stress levels in cancer cells, triggering programmed cell death (apoptosis). Synta did not reveal how many patients died prematurely or how much shorter their survival times were, but independent reviewers deemed the data severe enough to call for a halt to the trials. Had the trial succeeded, it would have been the first successful phase III trial for metastatic melanoma for 15+ years.

While disappointing, remember that failure is an intrinsic (and necessary) part of cancer research. Temporary setbacks like this will not impede progress toward more effective treatments for this devastating disease. Indeed, there are over 700 other clinical trials devoted to melanoma underway right now, including many promising new drugs!

Source:

"Synta Suspends Elesclomol SYMMETRY Trial in Metastatic Melanoma: Analysis by Independent DMC Identifies Safety Concerns." Synta Pharmaceuticals. 26 February 2009.

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