Takeda Initiates Study Of Hematide
Takeda Pharmaceutical has dosed the first patient in US in a clinical trial of the investigational new drug, Hematide, 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.