CytRx Aldoxorubicin Designated As Orphan Medicinal Product By EC

(RTTNews) - CytRx Corp. (CYTR), a biopharmaceutical research and development company specializing in oncology, Monday said its investigational drug aldoxorubicin has been designated as an orphan medicinal product by the European Commission or EC for the treatment of advanced soft tissue sarcomas.

"This European designation, together with our U.S. orphan designation, will facilitate our global development of aldoxorubicin to help improve the available treatment options for cancer patients suffering from this aggressive and difficult to treat cancer", said the CytRx President and CEO.

According to the European Medicines Agency or EMA guidelines, orphan medicinal product Designation provides up to 10 years of market exclusivity if the product candidate is approved for marketing in the European Union and the designation is maintained.

In addition, the status also permits EMA to assist in the drug's clinical development by being a part of clinical trial design and preparation of the product marketing application and the orphan medicinal product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant.

Aldoxorubicin, currently being evaluated in a global pivotal Phase 3 trial under a special protocol assessment, was already granted orphan drug designation by the Office of Orphan Product Development of the U.S. Food and Drug Administration for treating patients with soft tissue sarcomas and pancreatic cancer.