Cell Therapeutics Announces Study Data Set Cut-off For Phase III Pivotal Pixantrone (301) Trial

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 04 Nov 2008 - 1:00 PDT

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Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that it has closed the data set for preliminary analysis of the primary endpoint in the phase III EXTEND (PIX301) trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL) and it has provided Novartis notice that the data set has been closed. The primary endpoint for the study is the complete remission (CR) and unconfirmed complete remission (uCR) rate in patients receiving either pixantrone or another single agent chemotherapeutic drug. CTI plans to report top-line results in November.

"We are excited to have reached the end of the treatment phase and follow-up period for the pixantrone pivotal study and look forward to reporting top-line results in November," said James A. Bianco, M.D., CEO of Cell Therapeutics. "Complete remissions in this patient population with end stage advanced disease are seldom accomplished with the current standard of care. Pixantrone, if successful in achieving the study objectives, could offer these patients a significant benefit, and we would work with the FDA to submit an NDA in 2009."

CTI has an existing license and co-development agreement with Novartis for OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which also provides Novartis with an option to enter into an exclusive worldwide license to develop and commercialize pixantrone based upon agreed terms.

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 remission (CR) or unconfirmed complete remission (uCR) rate, time to tumor progression, and overall survival. 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.

About Pixantrone

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. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy 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 Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that 66,120 people will be diagnosed with NHL in 2008 and more than 19,000 are expected to die.

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 expectation that the Company will be able to report the top-line results in the fourth quarter, which is premised on the belief that final stage of analysis of this trial will not be subject to any unforeseen delays, which cannot be assured, statements relating to the timing, scope or expected outcome of the Company's clinical development of pixantrone, 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, whether or not Novartis elects to exercise their option on pixantrone and whether CTI and Novartis can agree on such terms 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.

Cell Therapeutics, Inc.
http://www.celltherapeutics.com