Cell Therapeutics: Monitoring committee says pixantrone trial should continue

By E. Janene Geiss

Philadelphia, Aug. 8 - Cell Therapeutics, Inc. reported Tuesday that a Data Monitoring Committee recommended that the company's randomized phase 3 trial of pixantrone should continue based on preliminary encouraging confirmed and unconfirmed complete response rates observed among the first 40 patients with aggressive non-Hodgkin's lymphoma.

The company said it plans to conduct a second interim analysis early next year, according to a company news release.

The interim analysis allowed the company to determine if the primary endpoint is tracking within the initial complete response rate projections or substantially higher than what was anticipated when the study was begun, officials said.

"Given the preliminary results reported by the independent Data Monitoring Committee, we believe another analysis of the primary endpoint after 100 patients have completed therapy is both warranted and ethical," Scott C. Stromatt, executive vice president of clinical development and regulatory affairs, said in the release.

The Extend clinical trial is a phase 3 trial for patients with relapsed, aggressive non-Hodgkin's lymphoma who have received two or more prior therapies. The trial is being conducted in 130 sites in 17 countries.

Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population.

The trial is designed to examine the complete response or unconfirmed complete response rate, time to tumor progression and overall survival.

The study was powered based on a complete response rate assumption of less than 5% for the control arm and a 10% improvement in complete response rate for the pixantrone arm.

The study is being conducted under a Special Protocol Assessment from the Food and Drug Administration, and pixantrone has received fast-track designation for this indication, officials said.

Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders.

Cell Therapeutics is a Seattle biopharmaceutical company focused on treating cancer.

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