Cell Therapeutics drops European drug application

Cell Therapeutics has dropped efforts to win European marketing approval for its Opaxio drug to treat non-small cell lung cancer, dealing a setback to one of the Seattle biotech company's two key drug programs.

The company will now "refocus its resources" for Opaxio on an ongoing late-stage clinical trial using the drug as a maintenance therapy for ovarian cancer. That trial has now enrolled 600 patients, the company said Tuesday.

It will also pursue using Opaxio — which combines the chemotherapy compound taxol with another molecule to better control its delivery — as a radiation sensitizer in the treatment of advanced esophageal cancer.

Cell Therapeutics said its Opaxio application to the European Medicines Agency, filed in March 2008, was withdrawn after the regulator's Committee for Medicinal Products for Human Use expressed "reservations" about a study on which the company relied. Opaxio was formerly known as Xyotax.

In its other key program, the company has filed with the Food and Drug Administration for approval of its drug Pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma.

Cell Therapeutics shares were down 4 cents, or 2.7 percent, to $1.43 after about two hours of trading Tuesday.