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November 15, 2012
07:36 EDTTHLDThreshold Pharmaceuticals reports updated Phase 2 Results for TH-302
Threshold Pharmaceuticals announced updated results from a Phase 2 study of TH-302, the company's investigational hypoxia-targeted drug, in patients with soft tissue sarcoma, including additional results from patients who were administered TH-302 as single agent maintenance therapy following induction with TH-302 in combination with doxorubicin. The results were reported at the 17th annual meeting of the Connective Tissue Oncology Society, or CTOS, taking place Nov. 14-17, in Prague, Czech Republic. Results for Overall Study Population-- Updated results for the 91 patients in the Phase 2 component of the study include: Median progression free survival, or PFS, of 6.7 months. Median overall survival of 21.5 months. One-year survival of 73%, and two-year survival of 44%. Overall best response of 36%. Results for TH-302 Single Agent Maintenance Therapy Population -- Of 91 patients enrolled in the study, 48, or 53%, continued on TH-302 maintenance therapy. The median number of treatment cycles with TH-302 was 4.0. Median PFS was 3.7 months. Median overall survival was 18.0 months. Overall best response (partial and complete responses, unconfirmed) of 54%; five patients who previously had stable disease prior to maintenance achieved a partial response, and one patient who previously had a partial response achieved a complete response.
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November 17, 2014
07:05 EDTTHLDThreshold Pharmaceuticals announces TH-302, bevacizumab Phase 1/2 interim data
Threshold Pharmaceuticals announced interim data from a U.S. investigator-sponsored Phase 1/2 clinical trial of the investigational anticancer drug TH-302 in combination with bevacizumab for the treatment of glioblastoma, or GBM, the most lethal form of brain cancer. All patients in the study had previously progressed on single-agent bevacizumab, the only FDA-approved therapy for GBM patients with progressive disease following prior therapy. As reported by the investigator, in a total of 22 evaluable patients, best responses included one complete response and three partial responses for a response rate of 18%, and ten stable disease assessments for a clinical benefit rate of 64%; eight patients had progressive disease. Median progression-free survival was 2.8 months, and median overall survival was 4.6 months. In addition, the FDA, through its Office of Orphan Product Development, recently awarded Dr. Brenner a grant for a Phase 2 clinical trial of TH-302 for the treatment of GBM. His is one of 15 grants the FDA awarded in 2014 in order to boost the development of medical device, drug, and biological products for patients with rare diseases. According to the FDA, the grants are for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.
November 13, 2014
07:10 EDTTHLDSociety for NeuroOncology to hold a meeting
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