Orphan drug designation granted from U.S. FDA for Efaproxyn.

2004 SEP 2 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics (ALTH) announced that the U.S. Food and Drug Administration (FDA) awarded orphan drug status to the company's lead clinical candidate, Efaproxyn (efaproxiral) for use as an adjunct to whole brain radiation therapy (WBRT) for the treatment of brain metastases in patients with breast cancer.

Efaproxyn is currently being investigated in a phase III clinical trial in this indication at leading cancer centers across North America.

The FDA may award orphan drug designation to drugs that target conditions affecting 200,000 or fewer U.S. patients per year and provide a significant therapeutic advantage over existing treatments.

The orphan drug designation provides for U.S. marketing exclusivity for 7 years following marketing approval by the FDA. Additionally, the designation qualifies a product for possible funding to support clinical trials, study design assistance from the FDA during development and other financial incentives.

"We are pleased to have been awarded the FDA's orphan drug designation for Efaproxyn," said Michael E. Hart, CEO and president of Allos. "This designation is a significant milestone in the development of Efaproxyn, and, if approved for marketing in this indication, will become an important component of our commercialization strategy."

In February, Allos initiated a phase III, randomized, open-label, multicenter trial called ENRICH (Enhancing Whole Brain Radiation Therapy (WBRT) In Patients with Breast Cancer and ...