Phase 2 clinical study of STA-9090 in NSCLC initiated

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it has initiated a Phase 2 clinical study of STA-9090 in non-small cell lung cancer (NSCLC). This is the fifth clinical study to be initiated on STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor with a novel chemical structure.

“Accumulating evidence supports the view of non-small cell lung cancer as a group of malignant diseases driven by distinct genetic abnormalities. Hsp90 is recognized as a potential therapeutic target in NSCLC due to its role in regulating numerous oncogenes that are believed to play an important role in the cause and development of NSCLC," said Mark Socinski, M.D., University of North Carolina, a co-principal investigator on the trial. "The potency, broad activity and acceptable side effect profile seen to date in both preclinical and early clinical studies with STA-9090 suggest that there may be a therapeutic role for this promising compound in the treatment of NSCLC.”

“Results presented at the AACR meeting in April 2009 and the Molecular Targets and Cancer Therapeutics meeting in November 2009 demonstrated that the Hsp90 inhibitor STA-9090 has greater potency compared to the first generation Hsp90 inhibitors, such as 17-AAG, to destabilize critical oncoproteins and components of their signaling pathways, including EGFR, ERBB2, KRAS, BRAF and MET,” said Geoffrey Shapiro, M.D., Ph.D., Dana Farber Cancer Institute, the other co-principal investigator on the trial. "These preclinical results, along with early clinical data from the Phase 1 solid tumor trials, where instances of prolonged stable disease and responses per RECIST criteria have been observed, support initiation of a proof-of-concept study of STA-9090 in NSCLC."

“STA-9090 is highly effective at inhibiting many of the key lung cancer cell growth and proliferation pathways as well as known mechanisms of resistance to EGFR inhibitors,” said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. “This includes activity against c-MET and the T790M mutation of EGFR, both of which have been shown to drive resistance to multiple therapies. This potent activity, together with the responses, safety profile, and clinical activity seen in our ongoing trials, provide a strong rationale for studying STA-9090 in NSCLC. We are excited to work closely with leaders in the field to explore the potential for clinical benefit.”

Synta also announced that additional preclinical results on STA-9090 in lung cancer will be presented at the American Association for Cancer Research-International Association for the Study of Lung Cancer (AACR-IASLC) Joint Conference on Molecular Origins of Lung Cancer on January 12, 2010 in Coronado, California.

STA-9090 is currently in four Phase 1 and Phase 1/2 trials. Synta expects to report results from these studies and initiate trials in multiple other indications in the first half of 2010.