FDA removes hold on CytRx's aldoxorubicin Phase III trials

The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company CytRx’s (Nasdaq: CYTR) aldoxorubicin trials.

Enrolment and dosing of new patients is now permitted as study sites’ Institutional Review Boards have approved revised trial protocols. The company believes that enrolment rates and timelines for trials will remain unchanged, and that enrolment will be completed for its ongoing pivotal Phase III trial by the end of 2015. The drug is being investigated to treat second-line soft tissue sarcoma. Subject to approval, CytRx is planning to launch aldoxorubicin in this indication in 2017.

Steven Kriegsman, chairman and chief executive of CytRx, said: "CytRx developed modified study parameters intended to avoid potential risks, while allowing the company to evaluate the therapeutic impact of aldoxorubicin for patients with soft tissue sarcoma, glioblastoma, Kaposi's sarcoma, and small cell lung cancer, among other trials. Our staff worked closely with the FDA Oncology Division to resolve all partial clinical hold issues as rapidly as possible. We expect enrollment and dosing in the ongoing clinical trials to be back underway soon."