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Threshold Pharmaceuticals Inc Reports Updated Phase 2 Results Including Analyses of Maintenance Therapy With TH-302 Following Induction Therapy With TH-302 Plus Doxorubicin In Soft Tissue Sarcoma

Thursday, 15 Nov 2012 07:30am EST 

Threshold Pharmaceuticals Inc 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. In the single-arm Phase 2 component of the study (403 trial), previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcomas were treated with TH-302 (300 mg/m2 on days 1 and 8 of a 21-day cycle) and doxorubicin (75 mg/m2 on day 1) for a maximum of six cycles. After six cycles, patients with stable disease, partial or complete responses, and with acceptable toxicity, were eligible to receive TH-302 maintenance therapy (300 mg/m2 on days 1 and 8 of a 21-day cycle). Response was assessed using RECIST criteria. Results for Overall Study Population (N=91) Updated results for the 91 patients in the Phase 2 component of the study include: Median progression free survival (PFS) of 6.7 months (95% CI: 6.2 to 8.1 months). Median overall survival of 21.5 months (95% CI 16.0 to 27.6 months). One-year survival of 73% (95% CI: 63% to 82%), and two-year survival of 44% (95% CI: 32% to 55%). Overall best response (partial and complete responses, unconfirmed) of36%. 

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