Potential NDA Submission in 2009
SEATTLE, March 25 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced today that enrollment is complete in the phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL). An analysis of the data is expected in the second half of 2008. Based on prior discussions with the U.S. Food and Drug Administration (FDA) the data could provide a registration path for pixantrone if final study results are adequate for submitting a New Drug Application (NDA) with the FDA in early 2009 with a potential approval in 2009. A total of 140 patients were enrolled in the study, 97 patients are currently evaluable according to Histological Intent to Treat, or HITT, criteria and will be included in the final analysis of the study.
"PIX301 examines the effectiveness of pixantrone in patients with relapsed and refractory diffuse large B cell lymphoma, a population where current therapies seldom induce complete remissions," said Jack W. Singer, Chief Medical Officer at CTI. "Based on a blinded current independent assessment of events in the trial we believe we have an adequate sample size of eligible patients to meet the primary objective of the trial."
About the EXTEND (PIX301) Clinical Trial
The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was conducted at 130 sites in 17 countries. Patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial was designed to examine the complete response (CR) or unconfirmed complete response (uCR) rate, time to tumor progression, and overall survival. The study was powered based on a CR rate assumption of less than 5 percent for the control arm and a greater than 10 percent improvement in CR rate for the pixantrone arm. The study was conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) and pixantrone has received fast track designation for this indication.
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. It is a novel DNA major groove binder that contains an aza- anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. A new chemical compound for the treatment of non- Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solid tumors, and immunological disorders, pixantrone is being developed by CTI to improve the activity and safety in treating cancers usually treated with the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com.
This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of pixantrone include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with pixantrone in particular
including, without limitation, the potential failure of pixantrone to prove
safe and effective for treatment of relapsed aggressive NHL, determinations
by regulatory, patent and administrative governmental authorities that the
PIX301 trial is insufficient to demonstrate pixantrone's safety and
effectiveness for commercial use, competitive factors, technological
developments, costs of developing, producing and selling pixantrone,, and
the risk factors listed or described from time to time in the Company's
filings with the Securities and Exchange Commission including, without
limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q.
Except as may be required by Italian law, CTI is under no obligation to
(and expressly disclaims any such obligation to) update or alter its
forward-looking statements whether as a result of new information, future
events, or otherwise.
|SOURCE Cell Therapeutics, Inc.|
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