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Synta Pharmaceuticals Corp. (NASDAQ: SNTA) $4.65. Today announced presentation of results from the ENCHANT-1 trial, a single-arm multi-center Phase 2 proof-of-concept study designed to evaluate ganetespib, the Company’s lead drug candidate, administered as monotherapy for the treatment of metastatic breast cancer. The results are being presented during a poster session at the 2013 San Antonio Breast Cancer Symposium in San Antonio, Texas.
The ENCHANT-1 trial is designed to evaluate the efficacy and safety of ganetespib monotherapy for treatment of HER2+ (Cohort A) or triple-negative (Cohort B) breast cancer (TNBC) patients previously untreated for locally advanced or metastatic disease. A third cohort was recently added to evaluate ganetespib in ER/PR+, HER2- (HER2-negative) patients.
Of the four patients in the HER2+ cohort evaluable for objective RECIST response by independent review, three patients (75%) achieved an objective response, including one complete radiological response (CR) and two partial responses (PR). One patient (25%) in this cohort achieved stable disease (SD).
Of the 11 patients in the TNBC cohort evaluable for objective RECIST response by independent review, two patients achieved PR (18%) and five patients achieved stable disease (SD, 45%), for a total disease control rate of 64%. As previously reported, one of the responding patients was adjudicated a clinical complete response at week 12 after receiving only three cycles of ganetespib therapy. Her disease was restaged to operable and she underwent a total mastectomy with curative intent. She is now receiving adjuvant chemotherapy.
At the week 3 PET assessment for metabolic response, three of the four patients (75%) evaluable by independent review in the HER2+ cohort achieved a metabolic response. In the triple-negative cohort, four of the 11 patients (36%) evaluable by independent review achieved a week 3 metabolic response.
Consistent with previously reported results, diarrhea, fatigue, and nausea were the most common adverse events associated with ganetespib treatment, and were mostly Grade 1 or 2 in severity.
What They Do: Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases.
Prothena Corporation (NASDAQ: PRTA) $27.39, along with Roche, today announced that they have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody for the treatment of Parkinson's disease, which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson's disease in 2014.
Under the terms of the agreement, Prothena will receive an upfront payment and near-term clinical milestone totaling $45 million. Prothena is also eligible to receive additional payments of up to $380 million upon the achievement of development, regulatory and first commercial sales milestones plus up to an additional $175 million in ex-U.S. commercial milestone payments. The total worldwide upfront and milestone payments may amount up to $600 million.
What They Do: Prothena Corporation plc is a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of a broad range of diseases that involve protein misfolding and cell adhesion, particularly on the discovery, development and commercialization of potential therapeutic monoclonal antibodies directed specifically to disease-causing proteins.
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