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news.CytRx has received orphan drug designation (ODD) for INNO-206 from the US Food and Drug Administration (FDA) as a treatment for the patients with soft tissue sarcomas.
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Following the completion of an ongoing open-label Phase 1b clinical trial, the company intends to start INNO-206 Phase 2b trial with late-stage soft tissue sarcomas in the second half of 2011.
The Phase 1b clinical trial is investigating the safety of administering doses of INNO-206 that are more than two to four times the standard dose of doxorubicin.
CytRx president and CEO Steven Kriegsman said their strategy to move quickly into a Phase 2b trial with INNO-206 in soft tissue sarcomas is further supported by the FDA’s approval of orphan drug designation.
"We envision a significant opportunity in this indication due to the objective clinical responses seen with INNO-206 in patients with sarcomas in an earlier Phase 1 trial as well as preclinical data," Kriegsman said.