Based on an analysis by an independent Data Monitoring Committee (DMC), Synta Pharmaceuticals has suspended the Phase III SYMMETRY (Synta Metastatic Melanoma Elesclomol Trial) trial, which was comparing elesclomol (STA-4783) in combination with paclitaxel to paclitaxel alone in chemotherapy-naïve patients with Stage IV metastatic melanoma. Following the suspension, shares in Synta fell from US$6.39 at the end of 26th February to close on 27th February at US$1.36, a decrease in value of nearly 79 per cent.
The decision was based on the results of an analysis by the DMC, which identified safety concerns, including an imbalance in overall survival, with a greater number of deaths occurring in the combination arm (elesclomol+paclitaxel) compared to the control arm of paclitaxel alone. The final analysis of the primary endpoint (progression-free survival) as assessed by independent reviewers has not been carried out yet. Elesclomol is an apoptosis stimulator, which acts by inducing oxidative stress in cancer cells by rapidly producing reactive oxygen species. Response to this oxidative stress leads to apoptosis.
Based on these findings, Synta has also revealed 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. The company is also in discussions with its collaborator, GlaxoSmithKline, about the future development of elesclomol. However, it looks likely that GSK will terminate the collaboration.
Such a huge setback could spell the end for Synta, especially in the current economic climate. However, the company has stated that it has both the resources and a diverse pipeline of novel drug candidates in the oncology and anti-inflammatory areas that will allow it to continue operating. The company has recently received two milestone payments that should help its current cash position. These include an up-front payment of US$16 million from Roche for the development of the Synta CRACM (calcium release-activated calcium modulator) programme for the treatment of inflammatory and autoimmune diseases, as well as committed research funding of US$9 million over the next two years. The second payment of US$10 million was received from GSK after Synta achieved a milestone related to the development of elesclomol.
Synta's pipeline includes: STA-9090, a novel heat shock protein 90 inhibitor that is currently in two Phase I studies in solid tumours; STA-5326 (apilimod mesylate), an oral interleukin (IL)-12/IL-23 inhibitor currently in a Phase IIa study in rheumatoid arthritis; STA-9584, a vascular disrupting agent for cancer in preclinical development; and additional programmes in the research and preclinical development stages. Synta shareholders will hope that these programmes prove more successful than elesclomol.
Matthew Dennis - Editor, Cancer Drug News
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