CytRx Corp., a biotech company specializing in oncology, today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s INNO-206 for the treatment of patients with soft tissue sarcomas.
CytRx holds the exclusive worldwide development and commercialization rights to INNO-206. The company’s goal is to initiate further clinical trials, which is leveraged by the FDA’s decision to grant the treatment orphan drug designation.
“Our strategy to move quickly into a phase IIb trial with INNO-206 in soft tissue sarcomas is further supported by the FDA’s approval of orphan drug designation,” Steven A. Kriegsman, president and CEO of CytRx stated in the press release. “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 I trial as well as preclinical data.”
INNO-206 is a novel conjugate of the chemotherapeutic doxorubicin, which is the only FDA-approved drug on the market for soft tissue sarcoma. INNO-206 was designed to improve efficacy and reduce adverse events, and in April 2011, was granted INNO-206 orphan drug designation for treating patients with pancreatic cancer.
CytRx said it plans to commence a phase IIb clinical trial in patients with late-stage soft tissue sarcomas later this year after the company completes the ongoing open-label phase Ib clinical trial in patients with advanced solid tumors who have failed standard therapies.
For more information visit www.cytrx.com