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Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today reported financial results for the quarter ended June 30, 2012 and provided clinical program updates.
“We continue to make strong progress in advancing our ganetespib program along two parallel paths to registration: as a monotherapy in certain targeted cancer patient populations, and in combination with chemotherapy in a broader patient population,” said Safi Bahcall, Ph.D., President and CEO. “We expect important clinical results over the next 12 months from trials evaluating both approaches, including interim results from our monotherapy trials and final results from the 240-patient Phase 2b portion of our Phase 2b/3 GALAXY trial in lung cancer.”
Ganetespib is currently being evaluated in over 20 clinical studies, including trials enrolling genetically-defined targeted patient populations – such as ALK+ lung cancer, HER2+ breast cancer, and triple-negative breast cancer – and trials in combination with other anti-cancer agents, such as the GALAXY trial, which evaluates ganetespib plus docetaxel vs. docetaxel alone for the second-line treatment of advanced non-small cell lung cancer.
The safety profile of ganetespib has been favorable in over 600 patients treated to date. The most common adverse event reported with ganetespib has been transient, mild or moderate diarrhea, which can be prevented or effectively managed with standard supportive care. There has been no evidence of the neurotoxicity, bone marrow toxicities, and alopecia characteristic of many chemotherapies.
Preclinical studies have shown monotherapy administration of ganetespib can potently inhibit some well-known cancer-promoting oncogenes, such as ALK or HER2. In clinical trials as a monotherapy, ganetespib has demonstrated objective responses or anti-tumor activity in patients with ALK+ lung cancer, mutant BRAF lung cancer, mutant KRAS lung cancer, mutant KRAS gastric cancer, HER2+ breast cancer, triple-negative breast cancer, renal cancer, colorectal cancer, and melanoma.
Ganetespib also potently inhibits certain well-known mechanisms that drive drug-resistance, such as HIF-1alpha and cell-cycle and DNA-repair genes. In preclinical models, ganetespib has been shown to enhance the activity of commonly used anti-cancer agents including chemotherapies (docetaxel, paclitaxel, vincristine, pemetrexed, gemcitabine, cytarabine, carboplatin, cisplatin), hormone therapies (tamoxifen, fulvestrant), kinase inhibitors (temsirolimus, lapatinib, crizotinib, vemurafenib, selumetinib), and others (bortezomib, bevacizumab).