In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a trial for metastatic prostate cancer and a monotherapy dose escalation study. "This is a stunningly disappointing day for all of us at Synta," said CEO Safi Bahcall in a conference call.
The SYMMETRY trial enrolled 630 subjects. Synta did not reveal how many patients died prematurely or how much shorter their survival times were, but an independent data monitoring committee deemed this data severe enough to call for a halt to the trials. Elesclomol is designed to elevate the oxidative stress levels in cancer cells, triggering programmed cell death. "We are enormously disappointed for melanoma patients, particularly because there are so few treatment options available. We will be working hard over the next several weeks to analyze and better understand the results from this trial," CMO Eric Jacobson, M.D., said in a statement.
The news is also a disappointment for GSK, which signed a $1.1 billion partnership deal for the drug in in October 2007. Had the trial met its endpoints, it would have triggered a $25 million milestone payment and been the first-ever successful Phase III trial for metastatic melanoma. The company has no drug on the market. It's next most advanced drug is STA-9090, a cancer treatment which is in Phase II trials. Synta shares nosedived 72 percent to $1.76 in after-hours trading.
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