Biopharmaceutical company Cell Therapeutics, Inc. (CTIC) announced Monday its updated results from the pivotal phase III clinical trial of pixantrone for patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma, who have failed two or more prior therapies. The results demonstrated that pixantrone consistently improved progression free survival across subgroups compared with other chemotherapy agents. Pixantrone increased median overall survival by 48% or 3.3 month over standard chemotherapy.
The updated results of the trial named EXTEND, or PIX 301, were presented in the annual meeting of the University of London during a session at the 2009 American Society of Hematology.
The PIX 301 EXTEND trial was a phase III single-agent trial of pixantrone, enrolling 140 patients, randomized to receive either pixantrone or another single-agent drug currently used for the treatment of the patient population and selected by the physician.
Trial results demonstrated improvement across primary and secondary endpoints of the study at a minimum of nine-month follow-up from end of treatment. Updated analyses with additional follow-up data supported the initial clinical trial results.
Non-Hodgkin lymphoma starts in cells called lymphocytes, a type of white blood cell which are part of the body's immune system. Some non-Hodgkin lymphoma are indolent, while others are very aggressive cancers. In 2009, the estimated new cases and deaths from non-Hodgkin lymphoma in the United States are 65,980 and 19,500, respectively.
Pixantrone is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. It is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration with action date on April 23, 2010. In September, the group applied for orphan drug designation to the European Medicines Agency or EMEA.
Results presented showed that pixantrone provided superior disease control rates over comparator arm with 22 of comparator recipients progressing within the first evaluation point versus 14 for pixantrone recipients. Complete response, partial response and progression free survival, or PFS, were robust irrespective of risk factors or prior therapy. The benefit on PFS was independent of risk factors.
Cell Therapeutics noted that subgroup analyses examining the effect of age, IPI score, disease status, or prior anthracycline doses on PFS showed that pixantrone consistently improved PFS across subgroups compared with other chemotherapy agents. In the nine-month follow-up period from end of treatment, pixantrone provided a 250% relative improvement in 1 year PFS over comparator and a 115% increase in median overall PFS. At 21 months, 14% of pixantrone patients remained free from disease progression versus 3% in the comparator arm.
"We are pleased that the PIX 301 EXTEND trial of pixantrone not only met its study objective but continues to demonstrate clinical benefit in the follow up period across patient demographics, and risk factors. We continue to work expeditiously with the FDA as we progress pixantrone through regulatory review to potential approval and commercialization," commented James Bianco, M.D., Chief Executive Officer of Cell Therapeutics.
CTIC finished Friday's trading at $1.18, on the Nasdaq. In the after hours, it picked up $0.04 or 3.39%.
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