SEATTLE, March 8 /PRNewswire-FirstCall/ -- James A. Bianco, M.D., President and CEO of Cell Therapeutics, Inc. (CTI) said today that the tragic death of Dana Reeve from lung cancer should be “a national wake up call for increased awareness and research into gender-based medicine.
“Women are affected differently from men when lung cancer strikes and respond differently to treatment. We need to better understand the biological role of estrogen in the development of non-small cell lung cancer (NSCLC).
“Since women have higher levels of estrogen than men, and younger women have higher levels of estrogen than older women, this may in part be responsible for their higher risk of developing NSCLC.
“We need to open the door to a new avenue of clinical research for gender-specific therapy, not only in lung cancer but in a number of cancers that are known to express the estrogen receptor. With increasing knowledge of human biology this is the ultimate promise of personalized medicine,” Bianco added.
CTI has received fast track designation from the FDA for its drug XYOTAX(TM) for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC), which is currently being studied in the PIONEER clinical trial -- the first approval trial for lung cancer exclusively targeting women. The PIONEER trial is targeting approximately 170 sites -- about half in the United States with the balance throughout the rest of world, including Eastern Europe and Latin America. CTI expects enrollment of 600 PS2 chemotherapy-naive women with advanced stage NSCLC to take about 12 to 14 months.
About XYOTAX
XYOTAX (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), 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. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Based on preclinical studies, it appears that XYOTAX is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. 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 over standard therapies.
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 forward-looking statements contained in this press release include statements about future financial and operating results and risks and uncertainties that could affect the development of CTI’s products under development, including XYOTAX and pixantrone. These risks include, but are not limited to, preclinical, clinical, and sales and marketing developments in the biopharmaceutical industry in general, and in particular including, without limitation, the enrollment and completion of planned and ongoing clinical trials, the timely submission and review of regulatory applications for XYOTAX, the potential failure of XYOTAX to prove safe and effective for or to be approved for use in the treatment of non-small cell lung and ovarian cancers, the potential failure of pixantrone to prove safe and effective for relapsed aggressive non-Hodgkin’s lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling CTI’s products under development, 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. 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.
CONTACT: investors, Leah Grant, +1-206-282-7100, or fax, +1-206-272-4434,or invest@ctiseattle.com, or media, Susan Callahan, +1-206-272-4472, orfax, +1-206-272-4434, or media@ctiseattle.com, both of Cell Therapeutics,Inc.
Web site: http://www.cticseattle.com/
