Presse: Regulatory Status Of RSR13

Allos Therapeutics, Inc. (ALTH)

Updates Regulatory Status Of RSR13

Allos Therapeutics, Inc. announced today that following a recent meeting with the Oncology Drug Products Division of the Food and Drug Administration (FDA), the Company may begin a rolling submission of a New Drug Application (NDA) for the Company´s Fast-Track investigational radiation sensitizer, RSR13 (efaproxiral), for the treatment of patients with brain metastases receiving whole brain radiation therapy. RSR13 is a synthetic small molecule that enhances the diffusion of oxygen to hypoxic (oxygen deprived) tumor tissue and has the potential to enhance the effectiveness of standard radiation therapy. This may represent the first investigational drug candidate in a new class of radiation sensitizing agents submitted to the FDA for approval.

"We believe our pre-NDA meeting with the FDA was productive, and we anticipate submitting the non-clinical sections as early as May 2003," said Markus Herzig, Vice President, Regulatory Affairs for Allos Therapeutics. "We will continue to work closely with the agency to ensure that our submission exceeds their expectations."

The NDA submission will be based on data from a single randomized Phase 3 study of 538 patients, one of the largest randomized studies ever conducted in this patient population. The submission will be supported by data from three Phase 2 studies where RSR13 has been shown to increase the efficacy of radiation therapy in patients with brain metastases, non-small cell lung cancer and glioblastoma multiforme. The Company has completed patient enrollment in the Phase 3 trial and is now collecting data and anticipates having top line results available in the second quarter of 2003.

"A Fast-Track designation means that the FDA may facilitate and expedite the review of an NDA, if the new drug is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need," added Herzig. "The FDA has given us the green light to begin the rolling submission and has communicated that they will consider an expedited review of our entire submission once they have seen our final data analysis."

Brain metastases are tumors that have spread to the brain from a primary malignant tumor in another part of the body. This condition occurs in approximately 170,000 cancer patients in the U.S. annually and occurs most often in patients with non-small cell lung cancer or breast cancer. Standard whole brain radiation, the primary mode of therapy for these patients, has been shown to prevent or reduce complications and to increase survival.