PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY - News) today announced that the independent Data Monitoring Committee (DMC), which provides oversight for the Phase 3 program for Hematide™, has completed another review and has informed the company that the cumulative safety data generated thus far from the EMERALD and PEARL Phase 3 trials support continuation of the studies. In the Phase 3 program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis.
“With each successive review by the DMC, the Phase 3 data are expanding and maturing,” said Arlene M. Morris, president and chief executive officer of Affymax. “These are important, and we look forward to additional DMC reviews as more data are generated. With all four of the Phase 3 trials fully enrolled, we look forward to continuing to generate data in the program and to finalize treatment by year end 2009.”
The Phase 3 program, which consists of four trials, was initiated in October 2007. Recently, Affymax announced that enrollment is complete in all four Phase 3 trials and reiterated its expectation for an NDA submission in 2010.
About Hematide
Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).
Affymax and Takeda Pharmaceutical Company Limited are collaborating on the development of Hematide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda. Affymax is conducting Phase 3 clinical trials which may support an NDA submission for Hematide to treat anemia associated with chronic renal failure.
About Anemia in Chronic Renal Failure (CRF)
Anemia in CRF affects many individuals with Chronic Kidney Disease (CKD). According to the National Kidney Foundation, 20 million Americans – 1 in 9 U.S. adults – have CKD. Anemia develops in the early stages of CKD and worsens as patients progress towards total kidney failure and need a dialysis machine to eliminate waste and water from their blood. In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs. Benefits of anemia correction in patients with CKD include decreased morbidity, hospitalization, and mortality.1
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.
This release contains forward-looking statements, including statements regarding the success of the collaboration, timing, design and results of the Company’s clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing, the timing of patient accrual and treatment in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in Affymax’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.
1. http://www.anemia.org/pdf/mon_Anemia_and_CKD.pdf
Contact:
Affymax, Inc. Sylvia Wheeler, 650-812-8700 Executive Director, Corporate Communications
Source: Affymax, Inc.
