Friday, February 27, 2009

Synta suspends melanoma drug study

By Marc Songini

Lexington-based Synta Pharmaceuticals Corp. has suspended the Phase 3 clinical study of its Symmetry drug, given safety concerns.

This week, Synta (Nasdaq: SNTA), announced it was doing so based on an analysis by the independent Data Monitoring Committee. The Phase 3 study was comparing elesclomol in combination with paclitaxel to paclitaxel alone in patients with stage 4 metastatic melanoma who have had no previous chemotherapy.

The committee identified safety concerns, including an “imbalance in overall survival,” with a greater amount of deaths occurring in the combination arm — elesclomol with paclitaxel — compared to the control arm, consisting of paclitaxel alone. Independent reviewers haven’t analyzed the primary endpoint yet.

Based on these results, Synta also announced that additional ongoing studies with elesclomol — including a study of elesclomol with docetaxel in hormone-refractory metastatic prostate cancer, and a monotherapy dose escalation study — will be suspended for further analysis of the Symmetry trial results. Synta is contacting investigators about appropriate patient notification and care.

Synta’s chief medical officer Eric Jacobson stated “we acted promptly to halt the Symmetry trial once it was evident that there were serious safety concerns.” The company will be working in the next several weeks to analyze and understand the trial results. The company intends to present detailed results as soon as a full analysis is done.

In the meantime, Synta will discuss with GlaxoSmithKline, its collaborator, the future development of elesclomol, a drug for programming cell death in cancer cells. Synta also plans to continue to develop its oncology and anti-inflammatory programs. 

Earlier this month, Synta received a milestone payment of $10 million from GlaxoSmithKline, around elesclomol.