Takeda doses first patient in Phase I anemia trial

The multicenter, open-label, repeat dose clinical trial in chemotherapy induced anemia (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 US 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.

Under the terms of the 2006 collaboration, Takeda and Affymax are jointly developing Hematide, and Affymax is now conducting a Phase III studies for the treatment of anemia in chronic renal failure patients in the US and Europe.