Cell Therapeutics Inc. (CTI) Files for Special Protocol Assessment (SPA) for XYOTAX(TM) PGT307 Lung Cancer Trial in Women
Tuesday March 20, 7:00 am ET
SEATTLE, March 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX: CTIC)
today announced it will file today for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of a phase III trial of combination therapy for women with advanced lung cancer. The trial, known as PGT307, will focus on women with normal estrogen levels, and will study XYOTAX(TM) (paclitaxel poliglumex) in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1 or 2. The enrollment target is 450 patients with an interim analysis planned in the first half of 2008.
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"The basis for this trial is the survival benefit we saw among pre- menopausal women in our STELLAR 3 trial, where the XYOTAX/carboplatin combination increased the median survival of this group by 34 percent over the control arm," said James A. Bianco, M.D., President and CEO of CTI. "Since doublet therapy is the standard first-line treatment for advanced NSCLC patients with normal performance status, this trial may reach a much larger segment of women with pre-menopausal estrogen levels who are diagnosed with the disease than our PGT306 single agent PS2 trial. We believe based on preclinical and clinical results that XYOTAX will be beneficial to this patient population by taking a negative risk factor in lung cancer -- estrogen -- and turning it into one that enhances response to therapy."
Laurie Fenton Ambrose, President of the Lung Cancer Alliance, noted, "We are excited to learn that CTI is moving forward on a new clinical trial for women with lung cancer. This is exactly the kind of research we need to help us better understand not only lung cancer's genetic differences, but to provide patients with improved treatment options." The Lung Cancer Alliance is a national non-profit organization dedicated solely to patient support and advocacy for people living with lung cancer or those at risk for the disease.
About XYOTAX
XYOTAX(TM) (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, 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. XYOTAX is being studied in non-small cell lung and ovarian cancers as well as in several investigator-sponsored trials for prostate and breast cancers.
Women and Lung Cancer
Lung cancer is the number one cancer killer of women in the United States -- more than breast and ovarian cancers combined. The American Cancer Society estimates that in 2007 there will be about 213,380 new cases of lung cancer in the United States -- up 22 percent from 2006. Of those new cases, 98,620 will be among women -- up 20 percent from a year ago. One in 16 women will develop lung cancer in their lifetime.
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. Except as may be required by Italian law, 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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Source: Cell Therapeutics, Inc.
