Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology

 News Release - June 4, 2007

Pre-menopausal Estrogen Levels Linked to Higher Death Rate Among Women Receiving Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC)

Cooperative group data presented at ASCO provides support for survival benefit seen in women with pre-menopausal estradiol levels treated with XYOTAX in STELLAR trials

CHICAGO, June 4 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today that data presented at the 2007 Annual Meeting of the American Society for Clinical Oncology (ASCO) provides independent supportive data validating the potential survival benefit of XYOTAX(TM) (paclitaxel poliglumex) over standard chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC) in women whose estrogen levels are in the normal range for pre-menopausal women.

"We now have independent confirmation from large prospective cooperative group studies that normal pre-menopausal estrogen levels are associated with a poorer response to standard chemotherapy for advanced NSCLC," said James A. Bianco, M.D., President and CEO of CTI. "This is the first time that this biomarker has been shown to have a strong negative correlation with survival in lung cancer and underscores the relevance of the significant survival advantage we observed with XYOTAX in this subset of women in our STELLAR trials. We believe our confirmatory gender-specific first-line trial (PGT307) qualifies for inclusion in the FDA's recently announced Critical Path Initiative as the first such study to explore the role of a negative risk factor -- estrogen -- and its potential positive metabolic interaction with a biologically-enhanced chemotherapeutic, XYOTAX."

"The results could be another step forward in making the case for the need for individualized medicine," Bianco concluded.

The STELLAR trials, conducted by CTI, were among the largest randomized, phase III trials for either first-line or second-line PS2 NSCLC, treating more than 1,700 patients.

"We applaud CTI's commitment to reporting these important issues so that the lung cancer community, particularly women, may have better and more treatment options," said Laurie Fenton Ambrose, President of the Lung Cancer Alliance.

Serum free estradiol (E2) levels are prognostic in men with chemotherapy-naive advanced NSCLC and PS 2 (Abstract #7683)

In a poster presentation, Helen Ross, M.D., a thoracic oncologist in Portland, Or., presented data that show free estradiol (E2) levels in serum are prognostic in men as well as women with NSCLC. A retrospective analysis of estradiol levels from male participants in STELLAR 3 and 4 was conducted using stored serum samples. The analysis showed that men with higher levels of free E2 have shorter survival, consistent with the shorter survival noted in pre- menopausal women when compared to older women.

"Retrospective analyses of several datasets now show a consistent detrimental effect of estrogen on NSCLC survival in women and in men," said Ross. "Prospective studies with laboratory correlative studies will help define ways to exploit steroid hormone pathways in NSCLC treatment design using drugs like XYOTAX to overcome negative estrogen effects on outcome, particularly in women."

For copies of the poster presented by Ross, please refer to CTI's Web site at http://www.cticseattle.com/investors_news-updates.htm

Toxicity and survival by sex in patients with advanced non-small cell lung carcinoma (NSCLC) on modern Southwest Oncology Group (SWOG) trials (Abstract #7549)

Kathy Albain, M.D., Professor of Medicine, Director Thoracic Oncology Program, Director Breast Clinical Research Program, Cardinal Bernardin Cancer Center, presented a CTI-sponsored retrospective analysis of data from Southwest Oncology Group (SWOG) trials that showed younger women, under 60 years old, with advanced NSCLC have shorter survival than older women. As part of her presentation, she included information about estrogen levels in female patients on first-line phase III XYOTAX trials (STELLAR 3, STELLAR 4 and PIONEER) that showed estrogen levels, rather than age, are a determinant factor for survival. It was shown that age had no effect on survival if patients with comparable estradiol values were considered.

"We believe this confirmatory data shows women with higher estrogen levels have worse survival, irrespective of age," said Jack W. Singer, M.D., Chief Medical Officer at CTI. "We look forward to advancing our upcoming phase III trial, PGT307, to prove enhanced efficacy for XYOTAX in this high risk patient group."

For more information about the ASCO annual meeting, please refer to the conference Web site at http://www.asco.org/.

About XYOTAX

XYOTAX(TM) (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in TaxolŽ, 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 http://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.


Source: Cell Therapeutics

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