Healthcare Industry News: XYOTAX
News Release - April 2, 2008
European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for ReviewSEATTLE, April 2, 2008 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) today announced that the European Medicines Agency (EMEA) has accepted for review CTI's Marketing Authorization Application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). CTI submitted the MAA at the beginning of March. The validation of the MAA for XYOTAX initiates the marketing approval review process, which generally takes 15 to 18 months. The application is based on advice from the Scientific Advice Working Party, or SAWP, at the EMEA. The EMEA agreed that switching the primary endpoint from superiority to non-inferiority is feasible if the retrospective justification provided in the marketing application is adequate. The discussions with the SAWP focused on using the STELLAR 4 study as primary evidence of non-inferiority and the STELLAR 3 study as supportive of the MAA.
In the STELLAR 4 trial, single-agent XYOTAX resulted in comparable survival to gemcitabine or vinorelbine in first-line patients and, with the exception of neuropathy known to be associated with taxane therapy, demonstrated significant reduction in several clinically meaningful toxicities, such as severe neutropenia and infection, and in the requirement for transfusions and use of hematopoietic growth factor support. In addition to improved tolerability, XYOTAX offered more convenient administration compared to currently used treatments and a reduction in overall utilization of medical resources compared to gemcitabine or vinorelbine.
"CTI looks forward to working with the EMEA as it begins the review process for XYOTAX," said James A. Bianco, M.D., President and CEO of CTI. "This is an important step toward making XYOTAX available for lung cancer patients in Europe."
About Lung Cancer
Lung cancer is the most common malignancy worldwide. Non-small cell lung cancer (NSCLC) accounts for 80 percent of all lung cancer cases. Within the population of patients with NSCLC requiring chemotherapy, PS2 patients, which account for approximately 25 percent of this group, are a population with special requirements since they have poor survival with cytotoxic chemotherapy and targeted agents. PS2 patients represent a subgroup of patients who are ambulatory and capable of self-care, but are unable to carry out any work activities, although they are up and about more than 50 percent of waking hours. There are presently no drugs approved to treat PS2 patients with advanced NSCLC.
Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.
XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in TaxolŽ, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
About the STELLAR Trials
Completed in 2005, the STELLAR trials were among the largest randomized, phase III trials in either second-line NSCLC or first-line PS2 NSCLC patients. STELLAR 2 tested XYOTAX versus docetaxel for the potential second-line treatment of NSCLC patients. STELLAR 3 tested carboplatin in combination with either XYOTAX or paclitaxel for the potential first-line treatment of PS2 patients with NSCLC. STELLAR 4 tested XYOTAX versus either gemcitabine or vinorelbine for the potential first-line treatment of PS2 patients with NSCLC. While the STELLAR trials missed their primary endpoint of superior overall survival, the trials showed significant reductions in most of the severe toxicities associated with standard chemotherapy agents.
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 XYOTAX include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, risks that the marketing approval review of the XYOTAX MAA may not result in a marketing approval in Europe, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX in the various countries in Europe, 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 does not intend 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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