Threshold Pharma Up 7% After Receiving Orphan Drug Status

Threshold Pharmaceuticals, Inc. THLD today announced the European Commission has granted Orphan Drug Designation for TH-302, a hypoxia-targeted drug, for the treatment of soft tissue sarcoma. "Receiving orphan designation for TH-302 in soft tissue sarcoma in the European Union is an important achievement for Threshold," said Barry Selick, Ph.D., CEO of Threshold. "Soft tissue sarcoma is an aggressive form of cancer for which there is a significant unmet medical need. TH-302 was designed to selectively target hypoxic regions within tumors, which are believed to not be effectively treated with current therapy. The Orphan Drug Designation was granted as early studies of TH-302 have shown that it might be of significant benefit for patients with soft tissue sarcoma when combined with doxorubicin." Threshold Pharmaceuticals is currently conducting a pivotal Phase 3 study in soft tissue sarcoma comparing TH-302 in combination with doxorubicin against single agent doxorubicin. The same combination regimen of TH-302 with doxorubicin was investigated in the single-arm Phase 2 study. Data from this Phase 2 study were most recently presented at the Connective Tissue Oncology Society meeting in October of 2011. In February 2011, Threshold Pharmaceuticals announced that it had reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for the Phase 3 study which includes a primary efficacy endpoint of overall survival. The international, randomized, controlled Phase 3 clinical trial was initiated in September 2011, and is being conducted in partnership with the Sarcoma Alliance for Research through Collaboration. The trial is designed to enroll 450 patients with metastatic or locally advanced unresectable soft tissue sarcoma.