Affymax Says to Continue Studying Anemia Drug
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 HematideTM, has completed its first review of the data and 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.
"These are very important reviews by the DMC and we are pleased that the committee has recommended that the trials proceed," said Arlene M. Morris, president and chief executive officer of Affymax. "We continue to make progress in enrollment of patients in the four Phase 3 trials and look forward to additional DMC reviews as more data are generated."
The Phase 3 program, which consists of four trials, was initiated in October 2007. Recently, Affymax announced that enrollment is complete in PEARL 1, the first of those Phase 3 trials. The company continues to enroll in the other three studies and anticipates completion of enrollment by year end 2008.
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 for Hematide to treat anemia associated with chronic renal failure and Takeda initiated a Phase 1 clinical trial in the U.S. to evaluate Hematide to treat chemotherapy-induced anemia in prostate, breast and non-small cell lung cancer patients.
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.