Wednesday, March 11, 2009

Synta postpones 10-K filing, conference call

By Mass High Tech staff

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Still dealing with the effects of the suspension of trials of a cancer drug over safety concerns, Synta Pharmaceuticals Corp. reports it has postponed releasing its fourth-quarter and year-end 2008 financial results, as well as delaying its year-end conference call, all of which was scheduled for tomorrow.

Officials at Lexington-based Synta (Nasdaq: SNTA) say the company is putting off the release and call because it needs more time to consider the financial implications of the suspension of clinical development of Symmetry (elesclomol), including the Phase 3 clinical trial of the drug in metastatic melanoma.

Synta says it will file its 10-K with the U.S. Securities and Exchange Commission as soon as it can, which should be within the 15-day extension period allowed under SEC rules.

The suspension of the Symmetry Phase 3 study was based on an analysis by an 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 had 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.

Synta is in discussions with GlaxoSmithKline PLC, its collaborator, on 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. Also last month, Synta received a milestone payment of $10 million from GlaxoSmithKline, around elesclomol.

For fiscal 2007, Synta reported a loss of $63.5 million on revenue of $740,000.