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Threshold Pharma Says FDA Granted Orphan Drug Designation For TH-302

Threshold Pharmaceuticals, Inc. (THLD) announced that the US Food and Drug Administration, or FDA, has granted orphan drug designation for TH-302, a hypoxia-targeted drug, for treating soft tissue sarcoma.

Barry Selick, chief executive officer of Threshold Pharma, stated, "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. 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."

The company further noted that it 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.

by RTTNews Staff Writer

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