ZURICH: Swiss drug maker Roche Holdings AG announced Monday it is temporarily suspending recruitment into its phase II testing of the drug Cera, a treatment for anemic patients with advanced non-small cell lung cancer receiving chemotherapy.
The company said it is calling off the studies became of an imbalance in the number deaths in the study and on the recommendation of an independent Drug Safety Monitoring Board involved in the study. Treatment of already enrolled patients with the drug will, however, continue.
The phase II study was to assess the optimal starting dose of the drug in patients with the disease.
Investigators had reported all deaths to be unrelated to the study drugs. Roche said the numerical imbalance has been noticed in the number of deaths across the four arms of the study -- three arms with Cera and one with another drug darbepoetin alfa -- and it believed this could be in part by deaths reported to be due to the progression of the underlying cancer (stage IIIb and IV of non-small cell lung cancer).
The company has not noticed any such imbalance in previously completed studies using Cera in cancer patients receiving chemotherapy. In an ongoing study in Japan, there have been no reported deaths during the clinical trial period.
Cera forms part of a class of drugs that contain a natural protein, erythropoietin (EPO), which counters anemia by boosting the body's production of red blood cells.
Drug company Amgen had reported higher death risk among patients taking its drug Aranesp, which also contains EPO. Its another drug, Epogen, and Johnson & Johnson's drugs Procrit and Eprex also belong to this class.
There are 153 patients who are participating in the study. Roche said safety data from the patients continuing in the study will be closely monitored in association with the Drug Safety Monitoring Board. It is also investigating the potential causes for the imbalance.
Roche's Cera product has a brand name, Mircera. The company did not say how many deaths have taken place in the four arms of the trial.
Meanwhile, the company said its another drug, Avastin, has been recommended for use in Japan in patients with advanced or recurrent colorectal cancer. A formal approval should be coming by mid-year, the company said. The drug is expected to have potential sale of $8 billion a year. It works by stopping blood supply to tumors. It has already secured approval for the drug in the U.S. and Europe for treatment of colorectal cancer and non-small cell lung cancer.
