Tuesday, biopharmaceutical company Cell Therapeutics, Inc. (CTIC) said that following talks with the US Food and Drug Administration, or FDA, it expects to submit a rolling New Drug Application for reviewing its DNA intercalating antitumor agent, Pixantrone as a treatment for relapsed aggressive non-Hodgkin's lymphoma, or NHL, in the first quarter of 2009.
Cell Therapeutics would submit New Drug Application, or NDA, based on the end-phase single agent trial conducted on 140 patients with relapsed aggressive NHL, who had received two or more prior therapies and were sensitive to anthracyclines treatment. Patients on the trial were randomized to receive either pixantrone or another single-agent drug currently used for the treatment in this patient population.
According to the company, the study had achieved primary efficacy endpoint with high rate of confirmed and unconfirmed remissions with patients on pixantrone versus patients treated with standard chemotherapy. The drug-candidate also significantly increased the overall response rate in the patients.
Presently, the company said it expects a decision on the NDA before the end of 2009, if the drug-candidate receives priority review. Earlier in 2004, the study received special protocol assessment approval and the drug obtained fast track designation from the FDA.
Commenting on the decision, James Bianco, Chief Executive Officer said, that the company is on track to meet its objective of cashflow break even in the fourth-quarter of the year, with the potential for three drug approvals in 2009.
The stock closed Monday, at $0.0744 on the Nasdaq.
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