CELL THERAPEUTICS FILES FOR SPA OF NHL TRIAL

Cell Therapeutics has filed an application for a special protocol assessment (SPA) with the FDA for the design of its Phase III trial of pixantrone for patients with indolent non- Hodgkin's lymphoma (NHL).

The trial, PIX303, will examine the complete remission rates and time to disease progression of the combination regimen of fludarabine, pixantrone and rituximab compared with the combination of fludarabine and rituximab in the treatment of patients who have failed up to five prior treatments for relapsed or refractory indolent NHL. The trial is expected to enroll 300 patients.

"The impressive complete remission rates and durable survival data in our Phase II combination study for indolent NHL patients provides the rationale for conducting a Phase III study," James Bianco, president and CEO of the company, said. "Pixantrone has shown encouraging activity in both indolent and aggressive NHL, especially in the relapsed setting, paving a route for a potential registration across both types of NHL."

Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anticancer agents.

Anthracyclines have been shown to be very active clinically in a number of tumor types, according to the company. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce cardiotoxicity, as well as to potentially increase the activity and simplify administration of currently marketed anthracyclines.