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Sarcoma

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January 24, 2011

ARIAD Pharmaceuticals and Merck released positive results from a phase III trial of ridaforolimus, for the treatment of soft-tissue or bone sarcomas. This randomized, placebo-controlled, double-blind study, SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus), enrolled 711 subjects with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. The subjects received placebo or oral ridaforolimus administered at 40 mg a day for five consecutive days, followed by two days off, until disease progression. The primary endpoint of improved progression-free survival (PFS) compared to placebo was reached. Based on the full analysis of 552 PFS events, determined by an independent review committee, there was a statistically significant (p≡0.0001) 28% reduction by ridaforolimus in the risk of progression compared to placebo. Ridaforolimus treatment resulted in a statistically significant 21% (3.1 week) improvement in median PFS (ridaforolimus, 17.7 weeks versus placebo, 14.6 weeks). Based on the full analysis determined by the investigative sites, there was a statistically significant (p<0.0001) 31% reduction in the risk of progression compared to placebo. Ridaforolimus resulted in a statistically significant 52% (7.7 week) improvement in median PFS (ridaforolimus, 22.4 weeks versus placebo, 14.7 weeks).

January 28, 2008

Threshold released results from a phase II trial of glufosfamide for the treatment of soft tissue sarcoma. This open label trial enrolled twenty two subjects with metastatic and/or advanced unresectable soft tissue sarcoma, previously treated with one or two prior systemic therapies, in the United States. The primary endpoint was objective response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety. Tumor response was evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). Eight of eighteen (44%) evaluable subjects demonstrated a clinical benefit of stable disease or partial response. Renal failure and renal toxicities were the most common adverse events. Based on the results Threshold planned to evaluate different dosing regimens likely required to improve the therapeutic index.

September 20, 2004

GenVec has published positive results from a phase I study of TNFerade, their gene therapy for the treatment of soft tissue sarcomas of the extremities. The results, published in the September 1st edition of Clinical Cancer Research, found a regimen of TNFerade and radiation therapy produced no dose-limiting toxicities; mild flu-like symptoms, including chills, fever and fatigue, was the most common adverse event. Furthermore, of the 13 subjects who received the drug, 11 (85%) showed objective tumor response, including 9 partial responses and 2 complete. Furthermore, 10 of the 11 subjects who received the treatment prior to surgery achieved either a complete response or >50% tumor cell necrosis. The study enrolled a total of 14 evaluable subjects with soft-tissue sarcomas of the extremities, who received one of three regimens of TNFerade during weeks one and two of a two-to-five week course of standard radiation therapy. TNFerade is currently in phase II studies in the treatment of esophageal, pancreatic, and renal cancers.