The company is conducting a pivotal Phase III study in soft tissue sarcoma comparing TH-302 in combination with doxorubicin against single agent doxorubicin.
The same combination regimen of TH-302, a hypoxia-targeted drug, with doxorubicin was investigated in the single-arm Phase 2 (TH-CR-403) study.
Threshold CEO Barry Selick said 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," Selick added.