SEATTLE, June 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) recently presented preclinical and clinical data on XYOTAX(TM) (paclitaxel poliglumex) at the 46th Annual AFI (Associazione Farmaceutici Industria) Symposium in Rimini, Italy. The posters presented received awards for innovation and quality of scientific content.
"The recognition these posters received underscores the high quality of research being done at our Bresso, Italy facility," stated James A. Bianco, M.D., President and CEO of CTI.
CTI presented preclinical and clinical data on the gender effect and role of estrogen on XYOTAX pharmacokinetics (PK). One of the main proteolytic enzymes involved in degradation of the polyglutamate polymer is cathepsin B, whose expression is upregulated by estrogens. In a comparison of PK in two clinical studies (PGT202 and GOG9914), a difference in exposure to unconjugated paclitaxel was noted to be related to circulating estrogens. Preclinical models also suggest that intact ovarian function is associated with enhanced biodistribution of XYOTAX to lung tissues; however, cathepsin B activity, which is suppressed in oophorectomized rats (ovaries removed), could be restored to normal levels by estrogen supplementation.
"These PK data on gender and the role of estrogen are important because they support the theory of metabolism of XYOTAX in the presence of estrogen and provide further explanation for the results of phase III clinical studies that showed XYOTAX had enhanced clinical efficacy in women with advanced NSCLC, particularly premenopausal women," said Alberto Bernareggi, Ph.D., Managing Director of Cell Therapeutics Europe S.r.l.
In addition, CTI presented preclinical and clinical PK studies that showed XYOTAX is stable in the systemic circulation accumulates in tumor and releases paclitaxel progressively, providing prolonged tumor and systemic exposure. Tumor exposure was increased by a factor of 12 in preclinical models treated with XYOTAX compared to paclitaxel. This supports the improved tolerability profile and similar efficacy of XYOTAX compared to paclitaxel observed in the STELLAR 3 phase III trial, which compared XYOTAX in combination with carboplatin to paclitaxel in combination with carboplatin.
The posters are available on our web site at: http://www.cticseattle.com/investors_news-updates.htm.
About XYOTAX
XYOTAX(TM) (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. 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 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 include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the potential failure of XYOTAX to prove safe and effective for treatment of non-small cell lung cancer, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX, 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//
