Threshold Pharmaceuticals (Nasdaq: THLD) Receives US Orphan Drug Designation for TH-302

Chicago, IL 3/30/12 (StreetBeat) – Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for TH-302, a hypoxia-targeted drug, for the treatment of soft tissue sarcoma.

"Following our announcement on March 16 regarding the receipt of orphan drug designation in the EU, we are pleased to also have US orphan designation in place," said Barry Selick, Ph.D., CEO of Threshold. "The results of our Phase 2 study (TH-CR-403) in soft tissue sarcoma are certainly supportive of a pivotal trial underway in this difficult to treat cancer."

Threshold Pharmaceuticals is conducting a pivotal Phase 3 study (TH-CR-406) 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 (TH-CR-403) study. Data from this Phase 2 study were most recently presented at the Connective Tissue Oncology Society (CTOS) meeting in October of 2011. In February 2011, Threshold Pharmaceuticals announced that it had reached agreement with the FDA 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 (SARC). The trial is designed to enroll 450 patients with metastatic or locally advanced unresectable soft tissue sarcoma.

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