Affymax Provides Phase 3 Program Update for Investigational Drug, Hematide[TM], to Treat Anemia in Chronic Renal Failure.All Four Pivotal Trials Tracking Toward Year-End 2009 Completion, Topline Results Now Likely in Q2 2010 PALO ALTO, Calif. -- Affymax, Inc. (Nasdaq:AFFY) today announced that it has notified clinical trial sites to complete treatment of patients in the Phase 3 clinical program for the investigational drug, Hematide, by the end of 2009. The company expects a period of approximately four months for data gathering and analysis, prior to reporting topline results in the second quarter of 2010. This amended timeline is not expected to affect the timing for New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) submission. The Phase 3 clinical program involves approximately 2,600 chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be patients at more than 400 clinical trial sites. "While some additional patient follow-up will extend our time to study completion, we believe these collected data will further strengthen and support our statistical plan," said Arlene Morris, president and chief executive officer of Affymax, Inc. "However, consistent with our previous guidance, we still expect to submit an NDA for Hematide in chronic renal failure in 2010 if all goes as planned." The Hematide Phase 3 program consists of four open-label, randomized controlled clinical trials randomized controlled clinical trials, n.pl medical research studies in which one or more groups are formed by random assignment to treatments and controls. Allows groups to be more equivalent when comparing he effects of treatment. in the U.S. and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. The trials in non-dialysis patients, called PEARL 1 and PEARL 2, are evaluating the safety and efficacy of Hematide compared to darbepoetin alfa darbepoetin alfa Aranesp Pharmacologic class: Recombinant human erythropoietin Therapeutic class: Hematopoietic Pregnancy risk category C FDA Boxed Warningin correcting anemia and maintaining hemoglobin levels over time.In dialysis patients, the trials, called EMERALD 1 and EMERALD 2, are evaluating the safety and efficacy of Hematide and its ability to maintain hemoglobin levels in the target range when patients are switched from epoetin alfa e·po·e·tin al·fa n. A recombinant preparation of human erythropoietin used to treat some forms of anemia. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: or epoetin beta to Hematide. Analysis of efficacy for each study is based on assessments of non-inferiority to the comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. drugs. The primary efficacy endpoint is the mean change in hemoglobin from baseline. The hemoglobin target range is 11-12 g/dL for studies in non-dialysis patients and 10-12 g/dL for studies in dialysis patients. In all studies, Hematide is dosed once every four weeks while comparator drugs are dosed more frequently in accordance with their respective product labels. Treatment in each study is planned until the last patient has been in the study for approximately 52 weeks. The primary assessment of safety will be an analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from all four Phase 3 trials. The duration of the Phase 3 trials depends on a sufficient number of cardiovascular safety events for statistical analysis. About Hematide Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis erythropoiesis /eryth·ro·poi·e·sis/ (-poi-e´sis) the formation of erythrocytes.erythropoiet´ic e·ryth·ro·poi·e·sis n. The formation or production of red blood cells. stimulating agent (ESA 1. (architecture) ESA - Enterprise Systems Architecture. 2. (body) ESA - European Space Agency. ). Affymax and Takeda Pharmaceutical Company Takeda Pharmaceutical Company Limited (武田薬品工業株式会社 Limited are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials are being conducted to investigate the potential for Hematide to treat anemia associated with chronic renal failure. About Anemia in Chronic Renal Failure (CRF CRF abbr. chronic renal failure CRF Chronic renal failure ) Anemia in CRF affects many individuals with Chronic Kidney Disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is (CKD See count-key-data. ). According to the National Kidney Foundation Not to be confused with American Kidney Fund. The National Kidney Foundation, Inc. (NKF) is a major voluntary health organization in the United States. Its mission is to prevent kidney and urinary tract diseases, improve the health and well-being of individuals and , 26 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 kidney failure or renal failure Partial or complete loss of kidney function. Acute failure causes reduced urine output and blood chemical imbalance, including uremia. Most patients recover within six weeks. 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 committed to 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 and room temperature stability, the cardiovascular event rate in our Phase 3 program, the timing of patient accrual 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 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion