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Cell Therapeutics, Inc. (CTI) Plans to Submit Marketing Applications for Potential Approval of XYOTAX(TM) in the United States and Europe
Would Be First Submission Exclusively Targeting Survival in Women With Lung Cancer
SEATTLE, Aug. 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) announced that it has decided on its strategy for seeking registration and approval for XYOTAX
. In the United States, CTI plans to submit a New Drug Application (NDA) and seek approval for XYOTAX as first-line monotherapy for women with advanced non-small cell lung cancer (NSCLC) who have poor performance status (PS2). The filing in Europe will also seek use as monotherapy in first-line PS2 patients with NSCLC, but is not expected to be limited to women; however, additional input on the statistical interpretation of non-inferiority will be needed from the scientific committee of the European Medicines Agency (EMEA) prior to submitting a Marketing Authorization Application (MAA).
"We believe that the survival data demonstrated among women in the STELLAR 3 and 4 trials are important enough to warrant review and consideration for approval. Based on our discussions with FDA, accelerated review and non- inferiority are not possible routes to pursue in the United States. We believe that a standard review based on the gender specific survival advantage observed in women in the STELLAR 3 and 4 trials is the most appropriate registration strategy in the US," stated Jack W. Singer, M.D., Chief Medical Officer of CTI. "While having missed the primary endpoints will make for a challenging review with the agencies, we are committed to conducting a study to try to confirm the survival advantage seen in women who received XYOTAX in the STELLAR 3 and 4 studies and plan to initiate such a clinical study in the fourth quarter of 2005. This would be the first submission exclusively targeting survival in women with lung cancer."
About Lung Cancer
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.
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.
or fax, +1-206-272-4434,
Susan Callahan, +1-206-272-4472,
, both of Cell Therapeutics, Inc.
Web site: http://www.cticseattle.com