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July 21, 2014
16:32 EDTSNTASynta Pharmaceuticals advances ganetespib into Phase 3 extension of AML LI-1
Synta Pharmaceuticals announced the advancement of ganetespib into the Phase 3 extension of the AML LI-1 trial. AML LI-1 is a multicenter, randomized Phase 2/3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine, in newly diagnosed elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who are not eligible for intensive chemotherapy. Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date. Advancement into the Phase 3 extension follows an interim analysis of results from 50 patients who received the ganetespib-cytarabine combination in the Phase 2 portion of the trial. The primary efficacy outcome in Phase 2 was rate of complete response. Per protocol, the Phase 3 extension will include an interim futility analysis and enroll approximately 200 patients in the ganetespib-cytarabine and the cytarabine alone arms, for a total of approximately 400 patients. The primary efficacy endpoint for the Phase 3 extension will include overall survival. The Company is currently in discussion with study investigators, and anticipates providing additional details, including the timing of study milestones, as they become formalized. The AML LI-1 trial is the first of three multicenter, randomized studies supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK to include a ganetespib treatment arm. AML LI-1 is being conducted under the auspices of the UK’s National Cancer Research Institute Haematological Oncology Study Group, with investigators in Denmark, France, New Zealand, and the UK, and under the sponsorship of Cardiff University, UK. The other two studies, to be initiated later this year, are the AML-18 trial, evaluating ganetespib with standard DA in patients over 60 years old who can tolerate intensive chemotherapy, and the AML-19 trial, evaluating ganetespib in combination with conventional chemotherapy in younger patients with AML.
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November 19, 2014
07:04 EDTSNTASynta Pharmaceuticals presents preclinical results from Hsp90 platform
Synta Pharmaceuticals announced that a poster highlighting preclinical results from its Hsp90 inhibitor Drug Conjugate platform is being presented at the 26th EORTC-NCI-AACR Symposium in Barcelona. “This poster highlights our ongoing evaluation of multiple candidates from the HDC platform. The preclinical results for our lead candidates not only demonstrate broad activity across several tumor types, but also the ability for HDCs to induce prolonged antitumor effects as compared to well-established cytotoxic agents,” said Weiwen Ying, Vice President, Discovery Chemistry at Synta. “In addition, the platform is not limited to using traditional cytotoxic therapeutics as payloads. A number of commonly used small molecule anticancer agents may also be incorporated, including tyrosine kinase inhibitors, proteosome inhibitors, small molecule immunotherapeutics, and other molecularly targeted agents. By leveraging the preferential retention characteristic of the Hsp90 targeting arm of an HDC in tumors, intratumoral exposure and antitumor potency for a wide array of payloads can be potentially improved." "We are encouraged by the progress the team has achieved to date with candidates arising from the HDC platform and the promise that the platform holds for both internal development and partnerships,” said Anne Whitaker, President and CEO of Synta. “We continue to evaluate options for efficiently advancing candidates from this platform and look forward to providing updates in the future.”

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