21 April 2017 - - The US Food and Drug Administration has reached an agreement with biopharmaceutical research and development company CytRx Corp. (NASDAQ: CYTR) on preparations for a New Drug Application submission for aldoxorubicin in soft tissue sarcomas. STS remains a high unmet medical need, the company said.

CytRx said its goal is to submit a rolling NDA under section 505(b) (2) to the FDA for soft tissue sarcomas in the last quarter of 2017. CytRx also plans to discuss with the European Medicines Agency a path to filing a Marketing Authorization Application.

The commercial launch of aldoxorubicin is still projected for 2018 in the United States. Aldoxorubicin has received Orphan Drug Designation by the FDA for the treatment of STS.

Orphan designation provides several benefits including seven years of market exclusivity after approval, certain Rand D related tax credits and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.

The proposed product label would include the treatment of soft tissue sarcomas. New data could allow future use of aldoxorubicin in neoadjuvant (pre-surgery) settings, as well as a replacement for doxorubicin in combinations.

CytRx is also working on a market expansion strategy which could include other indications for aldoxorubicin including combinations with other chemotherapeutics and immunotherapies.

The company said it is under confidentiality agreements with a number of companies for a commercial partnership for the marketing of aldoxorubicin. The company believes those active discussions may be further advanced by this latest news.

CytRx is specialising in oncology. CytRx currently is focused on the clinical development of aldoxorubicin, its improved version of the widely used chemotherapeutic agent doxorubicin.

The company is also expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.