akeda Pharmaceutical Company Limited (TSE: 4502) and Affymax, Inc. (Nasdaq: AFFY) announced that Takeda has dosed the first patient in the United States in a clinical trial of the investigational new drug, Hematide(TM), for the treatment of anemia in cancer patients undergoing chemotherapy.
Under the terms of the 2006 collaboration, Takeda and Affymax are jointly developing Hematide, and Affymax is now conducting Phase 3 studies for the treatment of anemia in chronic renal failure patients in the U.S. and Europe.
"We are pleased to begin the first U.S.-based clinical trial of Hematide in chemotherapy induced anemia (CIA)," said Masaomi Miyamoto, Ph.D., general manager of Takeda's pharmaceutical development division. "We will actively conduct development activities together with Affymax in order to bring this novel, potential treatment option to patients with anemia and physicians who treat them."
Arlene M. Morris, president and chief executive officer of Affymax, added "We look forward to continuing to support Takeda's efforts in the clinical development of Hematide in chemotherapy induced anemia. We are pleased with the data generated to date from our trial in CIA in Europe, which was completed last year and look forward to additional data in this indication from this first U.S.-based trial."
The multicenter, open-label, repeat dose clinical trial in CIA will enroll approximately 100 non-small cell lung cancer, prostate or breast cancer patients who have relapsed or progressed after previous treatment and who are anemic and receiving a taxane-containing chemotherapy. Patients will be dosed every three weeks (Q3W) until four weeks after discontinuation of their chemotherapy regimen, the occurrence of dose limiting toxicity, documented disease progression, or change in chemotherapy regimen.
The trial will evaluate the safety, pharmacokinetics and preliminary efficacy of various doses of Hematide in the correction of anemia. Initial dosing in this trial is based on results from an earlier trial in a more heterogeneous population of cancer patients that was conducted by Affymax in Europe in 2006. This new U.S. trial will aid in the selection of the appropriate dose or doses to be used in this more homogeneous patient population in additional later stage clinical trials.
About Hematide
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 anemia in patients with chronic renal failure and cancer patients receiving chemotherapy.
About Takeda
Located in Osaka, Japan, Takeda (TSE: 4502) 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. Additional information about Takeda is available through its corporate website, http://www.takeda.com.
About Affymax, Inc.
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(TM), is currently being evaluated in Phase 3 clinical trials for the treatment of anemia associated with chronic renal failure and is in clinical trials for the treatment of chemotherapy-induced anemia in cancer patients. For additional information, please visit http://www.affymax.com.
This release contains forward-looking statements, including statements regarding the timing, design and results of the Companies' clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Companies' 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 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 Companies undertake no obligation to update any forward-looking statement in this press release.
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