First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

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 the first patient has been treated in its clinical trial of STA-9090 in combination with docetaxel for the treatment of advanced solid tumor malignancies. This is the first clinical trial of STA-9090, a potent second-generation, small-molecule Hsp90 inhibitor with a chemical structure unrelated to the first-generation, ansamycin family of Hsp90 inhibitors (e.g., 17-AAG or IPI-504), in combination with another anti-cancer agent. Recent studies support synergistic anti-cancer activity of taxanes and Hsp90 inhibitors.

“We believe that STA-9090 is the leading Hsp90 inhibitor in clinical development today based on the encouraging safety profile and clinical activity seen to date, as well as the breadth of our clinical program”

"The scientific rationale for combining an Hsp90 inhibitor with taxanes is well established based on preclinical and prior clinical studies," said Suresh Ramalingam, M.D., Associate Professor, Department of Hematology/Medical Oncology and Chief of Medical Oncology, Winship Cancer Institute of Emory University. "STA-9090 has demonstrated high potency, early signs of clinical activity, and a favorable safety profile that make it ideal for combinations with docetaxel and other cytotoxic agents."

"The broad range of anti-cancer activity of docetaxel will make this combination an attractive option for several organ site malignancies including non-small cell lung, breast, prostate, head and neck, and gastric cancers," said R. Donald Harvey, Pharm.D., Assistant Professor of Hematology and Medical Oncology and Director of the Phase I Clinical Trials Program at Emory University. "The combination of STA-9090 and docetaxel could possibly expand the therapeutic potential of both agents." Docetaxel is also known to be active in ovarian, bladder, esophageal cancers, small cell lung cancer and sarcoma.

STA-9090 is currently being studied in 11 clinical trials including trials in non-small cell lung cancer (NSCLC), gastrointestinal stromal tumors (GIST), colorectal cancer, gastric cancer, small cell lung cancer (SCLC), acute myeloid leukemia (AML), and hepatocellular carcinoma. Additional trials will be initiated this year with a total of up to 15 trials expected by the end of 2010.

"We believe that STA-9090 is the leading Hsp90 inhibitor in clinical development today based on the encouraging safety profile and clinical activity seen to date, as well as the breadth of our clinical program," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "Combining STA-9090 with established anti-cancer drugs begins a second stage of exploring the ability of this compound to unlock the true potential of Hsp90 inhibition."

Study Design

The Phase 1, open-label, dose escalation study is designed to determine the recommended doses for the combination of STA-9090 and docetaxel in subjects with solid tumor malignancies. Patients must have histologically confirmed malignancy (ECOG Performance Status ≤2) that is metastatic or unresectable and evidence of disease progression prior to study entry. If patients have received prior treatment with docetaxel, there must be evidence of persistent or progressive disease. Secondary objectives will be to define the dose-limiting toxicities (DLT), pharmacokinetics, safety and tolerability as well as anti-tumor activity of the combination of STA-9090 and docetaxel. Dose escalation will continue until recommended doses are defined and then an additional cohort of 12-18 subjects will be enrolled to obtain additional safety and pharmacokinetic data. Subjects tolerating STA-9090 in combination with docetaxel can continue treatment until disease progression.