Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced it has filed for a Special Protocol Assessment ("SPA") with the U.S. Food and Drug Administration ("FDA") for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").
In the filing, CTI proposed to the FDA that the randomized study will compare pixantrone plus rituximab against the current standard regimens used to treat this patient group. This trial is planned to enroll relapsed or refractory aggressive B-Cell NHL patients who failed first-line to third-line treatment with standard chemotherapy and are not transplant eligible.
"We anticipate the majority of the patients for this trial will be enrolled in the U.S.," said Jack Singer, M.D., Chief Medical Officer at CTI. "There are no approved agents in this setting and no standard of care regimens so the unmet medical need is notable. We have proposed that the major endpoints for the trial will include response rate, progression free survival, as well as overall survival."
Following the FDA's feedback on the trial design and the endpoints, CTI plans to initiate this study later in 2010.
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