Threshold Pharmaceutical has received orphan drug designation for TH-302, a cancer drug, from the US FDA.
Threshold is presently testing TH-302 along with a commonly used chemotherapeutic agent, doxorubicin, in a late-stage trial to treat soft tissue sarcoma.
The orphan status can provide a seven-year marketing exclusivity for the drug from the date of approval.
The experimental drug had received orphan status from European health regulators.
Threshold chief executive Barry Selick said: "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."
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-orphan-drug-status-for-threshold-cancer-candidate-020412