Roche halts Ph II trial of anemia drug

Swiss drug major Roche is temporarily suspending recruitment in a Phase II trial of its continuous erythropoietin receptor activator Micera, which is being developed as a treatment for chemotherapy induced anemia, following safety concerns. In a statement, the firm said that it had taken the decision, which is in accordance with the advice of an independent Drug Safety Monitoring Board, due to "a numerical imbalance in the number of deaths across the four arms of the study...driven in part by deaths reported to be due to the progression of the underlying cancer."

Roche went on to say that the deaths were not thought to be associated with either the drug itself, or as a result of its elevation of hemoglobin levels. The firm said that it would closely monitor the safety of all the trial subjects enrolled, and would search for other possible explanations.

The news is another potential blow for drugs of this type, and adds to previous concerns that the mechanism of action they employ may inadvertently stimulate tumor growth.