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Affymax Announces New Data Presented on
the Long-Term Safety and Effectiveness of Hematide(TM) to Treat
Anemia in Chronic Renal Failure Patients with Monthly DosingOver 23 Month Period, Hematide Maintains Stable Hemoglobin Levels in CRF Patients PHILADELPHIA, Nov 06, 2008 (BUSINESS WIRE) -- Affymax, Inc. (Nasdaq: AFFY) today announced at the American Society of Nephrology Renal Week 2008 in Philadelphia positive results from a long-term safety and effectiveness study of its lead investigational therapy, Hematide(TM), which is being evaluated for the treatment of anemia in chronic renal failure patients. In the Phase 2 study analysis presented by Iain Macdougall, M.D., Hematide clinical investigator and honorary senior lecturer at King's College Hospital in London, 182 patients using Hematide once every four weeks (monthly) for up to 23 months successfully maintained average hemoglobin (Hb) levels within an 11 to 12 g/dL target range. "These data are encouraging because they demonstrate Hematide's ability to not only maintain average hemoglobin levels with monthly dosing, but to do so over a significant length of time," said Dr. Macdougall. "If the ongoing Phase 3 trials yield similar results as the Phase 2 data and if approved for marketing, Hematide could potentially provide healthcare professionals and patients with a differentiated alternative to current ESA (erythropoiesis stimulating agent) therapies available in the United States." A retrospective analysis of 115 patients from a Phase 2 study presented by Steven Zeig, M.D., Hematide clinical investigator and nephrologist at Pines Clinical Research, Inc. in Pembroke Pines, FL, showed that Hematide also maintains average hemoglobin levels within target in dialysis patients regardless of gender, age, race or diabetes as cause of chronic kidney disease. Because this study was not designed to evaluate efficacy in each demographic subgroup, no formal conclusions can be drawn from this analysis. Although the Hematide Phase 2 studies did not include a comparator group, to date, results indicate that the safety profile of Hematide appears (based on published data, including product labels) to be comparable to currently approved ESAs. In the Hematide Phase 3 study program, which is already underway with the first patients dosed in the fourth quarter of 2007, safety and effectiveness as co-primary endpoints will be compared directly to darbepoetin alfa in the pre-dialysis setting and epoetin alfa or epoetin beta for patients on dialysis. The Hematide Phase 3 program involves a total of approximately 2,400 chronic renal failure patients across four open-label, randomized controlled clinical trials in the U.S. and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. Both Phase 3 non-dialysis trials are already fully enrolled, with complete enrollment in the remaining two dialysis trials expected by the end of 2008. The company plans to submit a New Drug Application for Hematide in CRF in 2010. Additional Safety Information The Phase 2 data presented by Dr. Macdougall were combined from two ongoing rollover extension studies of Hematide in CRF patients (including those receiving hemodialysis and not receiving hemodialysis). Over a 23-month period study period, 151 of 182 patients experienced at least one treatment-emergent adverse event (AE). Twelve patients (6.6 percent) experienced at least one AE possibly related to Hematide treatment, including arteriovenous fistulae thrombosis (2 patients), increased blood pressure (3 patients) and increased blood potassium (3 patients). Serious adverse events (SAE) occurred in 64 of 182 patients. SAEs considered related to Hematide occurred in one non-HD patient, who experienced deep vein thrombosis of the leg. Nine patients died during the study period; none of the deaths were considered related to Hematide use. The Phase 2 data presented by Dr. Zeig are a post hoc analysis of an open-label, sequential dose finding trial. In this subanalysis, 6 of 115 patients reported AEs that were possibly related to treatment, including diarrhea, vomiting, fatigue, feeling hot, peripheral edema, positive blood occult, decreased platelet count, pain in extremity, headache, anxiety and hypertension. Thirty-four SAEs were reported in 29 of 115 patients; none were considered related to Hematide use. About Hematide Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an 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 disease. 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 Source Affymax, Inc. Sylvia Wheeler, 650-812-8700 Executive Director, Corporate Communications |