Affymax, Inc. (Nasdaq:AFFY) 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.

The Phase 3 program, which consists of four trials, was initiated in October 2007. Affymax announced that enrollment was complete in all four Phase 3 trials in November 2008 and reiterated its expectation for a 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 a 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

1. http://www.anemia.org/pdf/mon_Anemia_and_CKD.pdf

Source
Affymax, Inc.