Navigation Links
Affymax Announces Phase 2 Clinical Trial Results of Once-Per-Month,Hematide for the Treatment of Anemia in Patients with Early- and,End-Stage Chronic Kidney Disease

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 23, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced results to date from two separate Phase 2 clinical trials of Hematide(TM) in dialysis and non-dialysis chronic kidney disease (CKD) patients. The data showed that in treatment naive, non-dialysis patients Hematide could correct anemia when administered monthly at an appropriate dose. Similarly, the data in dialysis patients previously treated with three-times weekly Epoetin Alfa demonstrated that mean hemoglobin (Hgb) levels could be maintained at clinically acceptable levels following a switch to once monthly dosing of Hematide at an appropriate dose. The data were presented by Iain C. Macdougall, M.D. at the World Congress of Nephrology meeting being held in Rio de Janeiro.

"These data show that Hematide results in appropriate management of hemoglobin levels in a broad spectrum of patients with CKD from early-stage patients not on dialysis to patients with end-stage renal disease requiring continuous dialysis support," said Dr. Macdougall. "Anemia is a pervasive problem in the chronic kidney disease patient population. Being able to manage and control anemia allows treating physicians to focus attention on management of the patient's underlying renal disease."

At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 180 patients who had mostly completed six months of treatment at European and U.S. sites.

Of those, 90 treatment naive CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to greater than 11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patie nts previously treated with Epoetin Alfa were switched to Hematide once every four weeks. The mean baseline Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1 g/dL at the end of six months of treatment. Hematide was generally well tolerated with an adverse event profile consistent with the chronic kidney disease patient population.

Anne-Marie Duliege, M.D., vice president, Clinical, Medical and Regulatory Affairs for Affymax added, "As we prepare for Phase 3 clinical trials for Hematide, these data support our goal to evaluate the product in a broad CKD patient population. The Phase 3 studies will assess the safety and efficacy of Hematide in these patient populations and will generate sufficient clinical data to assist physicians in optimizing anemia management in their patients."

About Hematide

Hematide is a novel synthetic, pegylated peptide that binds to and activates the erythropoietin receptor. The product is being developed for treatment of anemia in chronic kidney disease and cancer.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company developing novel peptide-based drugs to improve the treatment of serious and often life-threatening conditions. Affymax's lead product candidate, Hematide(TM), is currently in Phase 2 clinical trials for the treatment of anemia associated with chronic kidney disease and cancer. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the timing, design and results of the Company's clinical trials and drug development program, 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, regulator y requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in the Company's Annual Report on Form 10-K 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.

Contact

Affymax, Inc.
Executive Director, Corporate Communications
Sylvia Wheeler, 650-812-8861


'"/>




Related medicine technology :

1. Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia
2. Affymax Announces Results From Phase 2 Clinical Trial of Hematide for the Treatment of Anemia in Dialysis Patients
3. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
4. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
6. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
7. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
8. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
9. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. Protox Announces Positive Clinical Data from Prostate Cancer Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
(Date:6/23/2016)... 23, 2016 Roche (SIX: RO, ROG; OTCQX: ... its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated ... shock. With this clearance, Roche is the first IVD ... solution for sepsis risk assessment and management. ... and PCT levels in blood can aid clinicians in ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/25/2016)... ... , ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter ... bar too high can result in disappointment, perhaps even self-loathing. However, those who set ... , Research from PsychTests.com reveals that behind the tendency to set low ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Marcy was in a crisis. Her son James, ... out at his family verbally and physically. , “When something upset him, he couldn’t control ... use it. He would throw rocks at my other children and say he was going ...
Breaking Medicine News(10 mins):