Synta Pharmaceuticals Corp, announced that based on an analysis by an independent Data Monitoring Committee (DMC), it has suspended the Symmetry trial, the phase-3 clinical study comparing elesclomol in combination with paclitaxel to paclitaxel alone in chemo-naïve patients with stage IV metastatic melanoma.
The decision to suspend the Symmetry trial was based on the results of an analysis by the independent DMC which identified safety concerns, including an imbalance in overall survival (OS), with a greater number of deaths occurring in the combination arm (elesclomol with paclitaxel) compared to the control arm (paclitaxel alone). The final analysis of the primary endpoint (PFS) as assessed by independent reviewers has not been carried out yet.
Based on these findings, Synta also announced that additional ongoing studies with elesclomol, including a study of elesclomol in combination with docetaxel in hormone-refractory metastatic prostate cancer and a monotherapy dose escalation study, will be suspended pending further analysis of the results of the Symmetry trial. Synta is contacting investigators regarding appropriate patient notification and care.
"Our first concern is for the safety of patients, and therefore we acted promptly to halt the Symmetry trial once it was evident that there were serious safety concerns," said Eric Jacobson, chief medical officer. "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."
"I would like to thank the patients who participated in this trial and the many investigators, healthcare professionals and Synta employees who have worked so hard on the development of elesclomol for whom this result is also very disappointing," said Safi Bahcall, president and chief executive officer of Synta Pharmaceuticals. "We will present detailed results in an appropriate scientific venue as soon as a full analysis has been completed. In the interim, we will be in discussions with our collaborator, GSK, about the future development of elesclomol."
"While this is a considerable setback, Synta has both the resources and a diverse pipeline of novel drug candidates that will allow us to continue to develop our oncology and anti-inflammatory programs," said Dr Bahcall. "We remain committed to bringing new treatment options to patients in these two major disease categories."
On its third quarter 2008 earnings call, Synta said that it expected to end the year with between $65 million and $70 million in cash and receivables. Synta recently concluded an agreement with Roche for the development of the Synta CRACM (Calcium Release-Activated Calcium Modulator) programme for the treatment of inflammatory and autoimmune diseases, and which provided an upfront payment of $16 million in cash as well as committed research funding of $9 million over the next two years and full preclinical and clinical cost reimbursement. Synta also recently announced that had achieved a milestone related to the development of elesclomol, earning an additional $10 million payment from GSK.
Synta has a strong pipeline of products, including STA-9090, a novel Hsp90 inhibitor that is currently in two phase-1 dose escalation studies in solid tumours; apilimod, an oral IL-12/IL-23 inhibitor currently in a phase-2a study in rheumatoid arthritis; STA-9584, a vascular disrupting agent for cancer in pre-clinical development; and additional programs in the research and preclinical development stages.
Synta Pharmaceuticals Corp is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases.