Affymax, Inc. (Nasdaq: AFFY) today announced that it has instituted a quiet period to curtail discussions with the investor community and the media in connection with the analysis of Phase 3 results for the investigational drug, Hematide, in four clinical trials (PEARL 1, PEARL 2, EMERALD 1 and EMERALD 2) which evaluated Hematide for the treatment of anemia in chronic renal failure patients.
As analysis of data from the first of the four trials begins, the company expects that full data gathering and analysis will take a period of weeks before top line results are announced some time in June 2010. The company expects to lift the quiet period following disclosure of Phase 3 results.
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 are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized in the European Union and Japan by Takeda.
Source
Affymax, Inc.