Sci-Reykjavik2007.org

The Myelodysplastic Syndromes (MDS) Foundation supports the decision by the U.S. Food & Drug Administration (FDA) to extend the label for VIDAZA (azacitidine) to include data from the AZA-001 clinical trial. Results from the trial found that azacitidine is the only agent which has been shown to extend survival in MDS patients.

Data from the AZA-001 trial was recently presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting and found that azacitidine nearly doubled the two-year survival rate for higher-risk MDS patients compared to conventional care regimens (CCR) with a mean survival of 24.5 months compared to 15 months for patients who received CCR.

"We are extremely encouraged by the results of the AZA-001 trial which for the first time showed that survival could be extended for patients with higher-risk MDS," said Kathy Heptinstall, Operating Director of the Myelodysplastic Syndromes Foundation, "Roughly 30 percent of patients diagnosed with MDS will progress to acute myeloid leukemia (AML), but treatment with VIDAZA significantly delays this progression. VIDAZA not only has great survival data in MDS, but can also prevent progression to AML."

Regenerx Biopharmaceuticals, Inc. (AMEX:RGN) announced that it completed enrollment of its first of four ongoing Phase II clinical trials. The trial is a double-blind, placebo-controlled, dose-escalating clinical trial evaluating the safety and efficacy of the Company's topical drug candidate, RGN-137, in seventy-two patients with pressure ulcers who are being treated for up to 84 days or less if fully healed. RGN-137 is a formulation of thymosin beta 4 specifically for topical delivery to dermal wounds. Twenty-two wound care centers and hospitals in the United States have participated in the study. The Company expects to report results in the fourth quarter of 2008.

"Clearly, we are excited about reaching this important milestone. While each of our Phase II trials will stand on its own and give us valuable information in separate medical indications, this trial will give us the first information on RGN-137's safety and efficacy in dermal wound healing. Currently there are no pharmacological agents approved for improving the healing of pressure ulcers and we look forward to reporting the results once they are available," stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.