Healthcare Industry News: PGT306
News Release - January 10, 2007
Cell Therapeutics, Inc. (CTI) Files for Special Protocol Assessment (SPA) With FDA for XYOTAX Lung Cancer Trial in WomenCEO Reviews 2006 Accomplishments and Milestone Targets for 2007
SEATTLE, Jan. 10 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) 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 phase III trial of XYOTAX for women with advanced lung cancer. The trial, PGT306, will focus exclusively on women with normal estrogen levels, the subset where XYOTAX demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 poor performance status (PS2) women who have advanced stage non-small cell lung cancer (NSCLC) and have not received prior chemotherapy. Only women with normal estrogen levels either as a result of pre-menopausal age or hormone replacement therapy will be randomized in the follow-on study to the PIONEER trial.
"Through our clinical studies in 2006, we have gained important insights into the best lung cancer patient population to target our XYOTAX pivotal trial effort in order to minimize end-of-trial surprises while maximizing the probability of success. We look forward to feedback and guidance from the FDA on our phase III trial," said James A. Bianco, M.D., President and CEO of CTI. "Lung cancer continues to be the number one cancer killer of women. Better treatments are needed to combat this disease that will kill more than 70,000 women this year."
In addition, Bianco reviewed CTI accomplishments for 2006 and identified important Company milestones for 2007:
-- "In 2006 the Company made significant progress in positioning XYOTAX, if approved, for successful commercialization," said Bianco. "A major development was the establishment of a potential $285 million commercial and development partnership for XYOTAX with Novartis, providing the global expertise and resources of one of the leading multi-national oncology companies."
-- In addition the Company received positive advice and agreement from the EMEA's Scientific Advice Working Party (SAWP) to switch from the superiority endpoint in the STELLAR 4 trial to a non-inferiority endpoint for XYOTAX. CTI plans to file a marketing authorization application (MAA) in Europe in 2007 for XYOTAX as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in men and women PS2 patients. "Given the recent article in the Journal of the National Cancer Institute showing the economic toll of the hours lost to cancer care, we believe the SAWP agreement recognizes this important and often overlooked reality," said Bianco.
"For our other phase III product, pixantrone, we recently presented positive clinical data at the American Society of Hematology (ASH) meeting showing high overall responses from two pixantrone studies. In addition, based on interim data from the first 40 patients on the EXTEND trial, a randomized phase III study of pixantrone for patients with aggressive non-Hodgkin's lymphoma (NHL), the Data Monitoring Committee recommended the study continue," Bianco added.
"2006 was a rebuilding year for the Company, establishing an important partnership while advancing our two lead drug candidates toward market. With two key regulatory events for XYOTAX and pixantrone, 2007 promises to be a pivotal transition for the Company and its products."
Key Target Milestones for 2007
-- Reach Special Protocol Assessment agreement with FDA on PGT306 pivotal trial for XYOTAX in women with lung cancer and initiate enrollment at approximately 200 centers worldwide
-- Reach Special Protocol Assessment agreement with FDA on PIX303 pivotal trial for pixantrone in first-line and second-line indolent NHL and initiate enrollment at more than 100 centers worldwide
-- File a marketing authorization application (MAA) in Europe in 2007 for XYOTAX as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in PS2 patients
-- Conduct interim analysis on phase III pixantrone clinical trial in relapsed aggressive NHL (EXTEND trial) and if compelling, meet with FDA to discuss potential registration strategy
-- Maintain burn rate at 2006 level, continue to strengthen and de-leverage balance sheet
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 www.cticseattle.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 XYOTAX and pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX and pixantrone in particular including, without limitation, the potential failure of XYOTAX and pixantrone to prove safe and effective for treatment of non -small cell lung cancer and non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX and 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
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