Affymax, Inc. and Takeda Pharmaceutical Company Limited announced that Affymax has dosed the first patient in the phase III clinical programme of its lead investigational therapy, Hematide, for the treatment of anaemia in chronic renal failure patients.
"The initiation of our phase III programme for Hematide is a significant milestone for Affymax, which positions us closer to our ultimate goal of providing a convenient monthly treatment alternative to the many patients suffering with anaemia," said Arlene M. Morris, president and chief executive officer, Affymax. "We believe our program is uniquely designed to take advantage of the most current regulatory and medical strategies for the evaluation and use of erythropoiesis stimulating agents. Hematide is a novel ESA with the potential to offer monthly dosing to physicians and patients. Consistent with our previous guidance, we anticipate all trials in the Phase 3 renal program will begin enrolling patients by the end of the year with the goal of completing enrolment in each of the trials in 2008. We expect the submission of a New Drug Application for Hematide in chronic renal failure in 2010 if all goes as planned."
"We are very excited with the initiation of phase III program for Hematide. Together with Affymax, we are conducting development activities worldwide in both renal and oncology indications, and we are looking forward to bringing this novel treatment option to patients suffering with anaemia as soon as possible," said Mr. Yasuchika Hasegawa, president, Takeda.
The Hematide phase III program, involving a total of approximately 2,200 chronic renal failure patients, consists of four open-label, randomized controlled clinical trials in the US 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, will evaluate the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anaemia and maintaining haemoglobin levels over time. In dialysis patients previously-treated with EPO, the trials, called EMERALD 1 and EMERALD 2, will evaluate the safety and efficacy of Hematide and its ability to maintain haemoglobin levels in a corrected range compared to epoetin alpha or epoetin beta when patients are switched from either of these epoetins to Hematide.
Analysis of efficacy for each study will be based on assessments of non-inferiority to the comparator drugs. The primary efficacy endpoint will be the mean change in haemoglobin from baseline. The haemoglobin target range will be 11-12 g/dL for studies in non-dialysis patients and 10-12 g/dL for studies in dialysis patients. In all studies, Hematide will be dosed once every four weeks while comparator drugs will be dosed in accordance with their respective product labels. Treatment in each study will be continued until the last patient has been treated for 52 weeks. Assessment of safety will include an analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from all four phase III trials.
Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor and acts as an erythropoiesis stimulating agent. The product is being developed for treatment of anaemia in patients with chronic renal failure and cancer patients receiving chemotherapy.
Affymax, Inc. is a biopharmaceutical company developing novel drugs to improve the treatment of serious and often life-threatening conditions. Affymax's lead product candidate, Hematide, is currently being evaluated in phase III clinical trials for the treatment of anaemia associated with chronic renal failure and is in clinical trials for the treatment of chemotherapy-induced anaemia in cancer patients.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.