Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company
focused on discovering, developing, and commercializing small molecule
drugs to treat severe medical conditions, today reported that the U.S.
Food and Drug Administration (FDA) has approved resuming clinical
development of elesclomol, the Company's first-in-class oxidative stress
inducer.
“The collected clinical and preclinical data presented to the FDA and to
our external scientific advisory board provided compelling evidence for
resuming clinical development with elesclomol”
"The collected clinical and preclinical data presented to the FDA and to
our external scientific advisory board provided compelling evidence for
resuming clinical development with elesclomol,” said Vojo Vukovic, M.D.,
Ph.D., Chief Medical Officer, Synta. “The action by the FDA will allow
us to further evaluate the potential of elesclomol in treating patients
with cancer, incorporating the clinical experience and scientific
understanding gained through a full analysis of the most recent data.
Based on these results, we expect to initiate one or more clinical
trials for elesclomol in the second half of this year. Further details
will be announced over the coming months.”
The Phase 3 SYMMETRY(SM) trial of elesclomol in metastatic
melanoma was suspended in February 2009 based on an interim analysis
that identified possible safety concerns. Preliminary results from the
trial were presented at ASCO in May 2009 and Perspectives in Melanoma
XIII in October 2009. These results showed a differential response to
treatment with elesclomol based on level of baseline lactate
dehydrogenase (LDH), an established prognostic biomarker in melanoma and
a pre-specified stratification variable in the trial. The primary
endpoint of progression-free survival was achieved in the normal LDH
population, 68% of enrolled patients, with an acceptable safety profile.
In the elevated LDH population, 32% of patients, no difference was
observed between the two arms of the trial for the primary endpoint, and
a negative impact was observed for the survival endpoint.