PGT202 trial demonstrated survival advantage with paclitaxel poliglumex
Sep 28, 2005, 13:01, Reviewed by: Dr.
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"We are currently evaluating the effect of estrogen on the metabolism of XYOTAX in normal and cancerous tissues to provide mechanistic support for these important clinical results."
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By Cell Therapeutics, Inc.,
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women and results in more deaths per year than colorectal, breast, prostate, liver, and kidney cancers combined. Nearly 60 percent of people with lung cancer die within one year of their diagnosis and nearly 75 percent die within 2 years; figures which have not improved in 10 years. Lung cancer is expected to kill nearly twice as many women as breast cancer this year.
At a presentation at the UBS Global Life Sciences Conference, Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX: CTIC) presented new results from a recently completed phase II clinical trial of XYOTAX in the first-line treatment of men and women with advanced non-small cell lung cancer (NSCLC).
In that single arm study, known as PGT202, the 35 women who received XYOTAX plus carboplatin had a 36 percent probability of living at least 1 year compared to only 16 percent in the 39 men receiving the same regimen. A pooled analysis of XYOTAX treated patients from STELLAR 3, STELLAR 4 and the PGT202 trial demonstrated a statistically significant (p=0.004) survival advantage for women treated when compared to men, with women having a 39 percent probability of surviving at least 1 year compared to 25 percent of men (HR =1.37, log rank p = 0.014 N = 463 patients). The Company previously reported that in a combined analysis of STELLAR 3 and 4, women treated with XYOTAX survived significantly longer than women treated on the standard chemotherapy control arms of these studies.
"To the best of our knowledge this is the first time a drug therapy for advanced lung cancer has consistently demonstrated such a strong survival advantage for women compared to men or compared to women randomized to treatment with standard chemotherapy," noted Jack W. Singer, M.D., Chief Medical Officer at CTI. "We are currently evaluating the effect of estrogen on the metabolism of XYOTAX in normal and cancerous tissues to provide mechanistic support for these important clinical results."
In August, CTI outlined its plans to file a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe in 2006 based on the results of its Stellar 3 and 4 trials.
Several studies have indicated that compared to men, women who smoke are more likely to develop lung cancer at a younger age and at lower levels of exposure to cigarette smoke. Non-smoking women are at higher risk for developing lung cancer than non-smoking men. Research has focused on the influence of genetic differences between men and women and on the role of estrogen to explain these findings. Estrogen enhances the effects of carcinogens in the environment and in smoke, possibly leading to a higher risk for NSCLC and once it occurs, appears to enhance its development. 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 for NSCLC. Developing therapies that are favorably influenced by estrogen may provide a gender-targeted therapeutic approach to the treatment of NSCLC. 
- Cell Therapeutics, Inc. Seattle
www.cticseattle.com
XYOTAX (paclitaxel poliglumex) is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. 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 trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor.
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 or to be approved for use in non-small cell lung cancer, risks that the results of any single STELLAR trial or the body of data from all 3 STELLAR trials will not be sufficient for approval of XYOTAX for the treatment of lung cancer, risks that our submissions will not be accepted by regulatory agencies or that any confirmatory trials will commence and will confirm a gender effect in women with 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.
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