Synta Pharmaceuticals has reached a key point in its development of the cancer therapy elesclomol. The developer is set to announce today that it has completed enrollment in a confirmatory Phase III trial, setting the stage to declare their success or failure in the coming weeks or months.
"We should have the data sometime between now and May," CEO Safi Bahcall tells FierceBiotech. Synta has a lot riding on the outcome. In October, 2007 GlaxoSmithKline signed a $1.1 billion partnership deal on elesclomol, which is now the subject of the 630-patient Phase III. The primary endpoint is progression-free survival, just as it was for Synta's successful Phase IIb trial of the melanoma drug. At the end of the Phase III study Synta will get a $10 million milestone payment and garner $25 million if the data comes in positive.
"This is the first drug that triggers cell death by oxidative stress induction," says Bahcall. It would also be the first successful Phase III trial for metastatic melanoma. And it would send a clear signal that elesclomol has considerable potential in the fight against other cancer types as well.
If the trial is successful, Lexington, MA-based Synta plans to file an NDA in the second half of this year and Synta has a co-promotion deal with Glaxo for the U.S. market. Positive data would bring Synta one step closer to fielding its own marketing force as it pursues other studies for elesclomol. Synta's Hsp90 inhibitor--STA-9090--meanwhile, is scheduled to move into a mid-stage trial.
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