Update on regulatory pathway for INNO 206 (aldoxorubicin) in soft tissue sarcomas (STS).- CytRx Corporation

CytRx Corporation announced an update on the regulatory pathway for a New Drug Application (NDA) submission for aldoxorubicin in soft tissue sarcomas (STS). The Company plans to submit a rolling NDA under section 505(b)(2) to the FDA for aldoxorubicin as a treatment for STS.

The 505(b)(2) pathway is designed for a new drug that contains the same active ingredient as a previously approved drug, also known as a reference drug. For aldoxorubicin, doxorubicin is the reference drug. The NDA submission is not reliant solely on the recently completed Phase III clinical trial in Soft Tissue Sarcoma (SIS) or overall survival results. Rather, CytRx's completed pharmacokinetic clinical trial, Phase IIb and Phase III trials in STS, along with preclinical safety and efficacy studies, will serve as "scientific bridges" between aldoxorubicin and doxorubicin. These studies, along with the published literature of doxorubicin's effectiveness and safety, will form the basis of the NDA filing for aldoxorubicin under the 505(b)(2) regulations.

The proposed product label would allow the treatment of soft tissue sarcomas. New data could support future use of aldoxorubicin in neoadjuvant (pre-surgery) settings, as well as a replacement for doxorubicin in chemotherapy combinations. CytRx is also working on a market expansion strategy which would include other indications for aldoxorubicin including combinations with other chemotherapeutics and immunotherapies.