Threshold Pharmaceuticals, Inc., in partnership with Sarcoma Alliance for Research through Collaboration (SARC), has announced the initiation of a Phase 3 randomized clinical trial of TH-302 in patients with soft tissue sarcoma. This pivotal international trial will enroll patients with metastatic or locally advanced unrespectable soft tissue sarcoma who have not received chemotherapy other then the adjuvant or neoadjuvant setting. The trial has been designed to evaluate the capability and the safety of TH-302 in combination with doxorubicin, in comparison to just doxorubicin alone.
Succeeding an end of Phase 2 meeting with the FDA, the Phase 3 protocol has been agreed upon under a Special Protocol Assessment (SPA). As a part of the assessment, the FDA has agreed that the planned analysis and the design of the study has adequately addressed the objectives that are necessary to support a regulatory submission needed for approval with enrollment anticipated to be completed by the end of the year 2013.
“Combining TH-302, a selective hypoxia-targeting prodrug, with doxorubicin, an agent with known activity in sarcoma, has a strong scientific rationale. TH-302 represents a novel concept in anti-cancer treatment. It was designed to deliver a cytotoxic agent to areas of a tumor that are often inaccessible to standard chemotherapies. We therefore expect that doxorubicin and TH-302 will complement one another by targeting the vascular components and hypoxic components, respectively, of a patient’s sarcoma,” said William D. Tap, M.D., Section Chief of Sarcoma Oncology at Memorial Sloan-Kettering Institute and principal investigator for this trial. “I’m excited to be a part of this collaboration between SARC and Threshold and I am looking forward to participating in this pivotal Phase 3 trial with the hope of establishing TH-302 as a new treatment for patients with sarcoma.”
“The proposed study is designed to confirm the encouraging results that we have previously reported in the Phase 1/2 study of soft tissue sarcoma patients treated with TH-302 in combination with doxorubicin,” said Sant P. Chawla, M.D., Sarcoma Oncology Center and principal investigator for the initial Phase 1/2 study. “The treatment of soft tissue sarcoma is a therapeutic challenge. Besides the approval of imatinib mesylate which was limited to gastrointestinal stromal tumors, there have been no new approved agents in first-line soft tissue sarcoma over the last 20 years. We look forward to working with Threshold and SARC.”
For more information on Threshold Pharmaceuticals Inc., visit their company website at http://www.thresholdpharm.com
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