Key Developments For Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp. (SNTA.O) (Consolidated Issue listed on NASDAQ Global Market)
Synta Pharmaceuticals Corp. Presents Preclinical Data On Hsp90 Inhibitor, STA-9090
Synta Pharmaceuticals Corp. announced that preclinical data presented shows that STA-9090, a synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrated strong activity in multiple tumor models, including lung cancer, gastrointestinal stromal tumors (GIST), prostate cancer, colon cancer, breast cancer, gastric cancer, pancreatic cancer, colon cancer, melanoma, acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, B-cell lymphoma, and multiple myeloma. Potent activity was shown in cancers resistant to treatment with imatinib (Gleevec), sunitinib (Sutent), and erlotinib (Tarceva), including models with genetic mutations known to make those cancers highly resistant to treatment, such as the BCR-ABL T315I mutation in leukemias, the EGFR T790M mutation in lung cancer, and the KIT Ex 11 V654A and D820A mutations in GIST. STA-9090 was also shown to have potency superior to 17-AAG, the first generation, ansamycin-family Hsp90 inhibitor, across multiple tumor models and gene mutation profiles. Other results important for considering future clinical development with STA-9090 were presented, including results showing that STA-9090 enhances the activity of the widely used cancer drug paclitaxel. STA-9090 is currently in four Phase 1 and Phase 1/2 trials. Synta expects to report data from these studies and initiate new trials across multiple tumor types later this year and in the first half of 2010.
Synta Pharmaceuticals Corp. Announces Updated Elesclomol SYMMETRYSM Data
Synta Pharmaceuticals Corp. announced that additional results from its Phase 3 trial (SYMMETRYSM) of elesclomol in combination with paclitaxel in metastatic melanoma was presented at the Perspectives in Melanoma XIII Conference by Steven O`Day, M.D., principal investigator and Chief of Research and Director of the Melanoma Program at the Angeles Clinic in Santa Monica, California. The data from the SYMMETRY trial presented at the Perspectives in Melanoma XIII Conference shows an important connection between patients` baseline level of LDH (lactate dehydrogenase), an established biomarker in melanoma, and treatment outcome with elesclomol. Patients with low and normal baseline levels of LDH showed an improvement in progression free survival (PFS), the primary endpoint of the study. The OS (overall survival) data for these groups are still highly censored and evolving; no difference has been observed to date between the treatment and control arms. In contrast, patients with high baseline level of LDH showed no PFS benefit and a decreased survival time relative to the control arm. These results, along with the results of other recent randomized clinical trials, suggest that baseline LDH status may evolve from a prognostic factor for the disease to a potentially predictive factor for treatment.
Synta Pharmaceuticals Corp. Initiates Fourth Trial of STA-9090
Synta Pharmaceuticals Corp. announced that it has initiated a Phase 1/2 clinical study of its heat shock protein 90 (Hsp90) inhibitor, STA-9090 in hematologic malignancies with a once-a-week dosing schedule. In March, Synta initiated the first Phase 1/2 clinical study of STA-9090 in hematologic malignancies with a twice-weekly dosing schedule. This is the fourth clinical study initiated on STA-9090, a synthetic, small molecule Hsp90 inhibitor with a chemical structure that is unrelated to the ansamycin class of Hsp90 inhibitors, including 17-AAG. The other ongoing clinical trials are once-a-week and twice-a-week dosing studies in patients with solid tumors. The open-label Phase 1/2 study in patients with hematologic malignancies is designed to identify the recommended dose of STA-9090 for further study in patients with hematologic malignancies, based on a once-weekly intravenous dosing schedule, and to characterize its safety and efficacy profile in this patient population.
Synta Pharmaceuticals Corp. and GlaxoSmithkline PLC End Elesclomol Collaboration Agreement
Synta Pharmaceuticals Corp. announced that GlaxoSmithkline PLC and Synta will end the collaborative agreement for the clinical development and commercialization of elesclomol effective no later than September 10, 2009. Worldwide rights to elesclomol will revert to Synta and Synta may pay GlaxoSmithkline PLC a low single-digit royalty on any potential future sales of elesclomol.
Synta Pharmaceuticals Corp. Announces Presentation Of Preliminary Results Of Phase 3 SYMMETRY Trial of Elesclomol
Synta Pharmaceuticals Corp. announced the preliminary results of the Phase 3 SYMMETRYSM trial of elesclomol in combination with paclitaxel in metastatic melanoma. The results are the subject of an oral presentation by Steven O`Day, M.D., Chief of Research and Director of the Melanoma Program, The Angeles Clinic and Research Institute, at the Annual Meeting of the American Society of Clinical Oncology. The SYMMETRY trial and other trials for elesclomol were suspended in February 2009 after a meeting of an independent Data Monitoring Committee for the SYMMETRY trial observed an imbalance in deaths in favor of the control (paclitaxel alone) arm. Database lock and final analysis for the primary endpoint of the trial, PFS, are expected in Q3 2009. Preliminary results for PFS, in the full intent-to-treat (ITT) population, consisting of the 621 patients who were evaluable by April 2009 out of 651 total enrolled patients. These results show a trend towards improvement in PFS, which did not achieve statistical significance (p=0.111; stratified log-rank test).
