Healthcare Industry News: paclitaxel
News Release - June 5, 2007
XYOTAX(TM) More Cost Effective With Fewer Side Effects Than Gemcitabine or Vinorelbine in Treating Non-Small Cell Lung CancerASCO publication highlights health care cost benefit of bioengineering paclitaxel
CHICAGO, June 5 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced that data published in the 2007 Annual Meeting of the American Society of Clinical Oncology (ASCO) abstracts showed reduced medical resource utilization (MRU) and associated costs with XYOTAX (paclitaxel polyglumex) treatment compared to gemcitabine or vinorelbine in treating patients with non-small cell lung cancer (NSCLC). The total average treatment cost, excluding drug costs, for XYOTAX patients was nearly half the cost of treatment for patients on standard chemotherapy ($2,518 vs. $4,834 per patient) and was associated with a significant reduction in many of the toxic side effects.
"This analysis shows XYOTAX, when used as a single agent and compared with standard single agent therapy with either gemcitabine or vinorelbine in NSCLC patients, had comparable efficacy as measured by overall survival. But notably, patients treated with XYOTAX had a clinical benefit in its side effect profile, and a substantial cost advantage over the standard agents," said Jack W. Singer, M.D., Chief Medical Officer of CTI. "These are important data in support of the clinical benefits associated with XYOTAX."
Medical Resource Utilization (MRU) and Costs Associated with XYOTAX(TM) (paclitaxel poliglumex; PPX) Compared to Gemcitabine (Gem) or Vinorelbine (Vin) In Non-Small Cell Lung Cancer (NSCLC) Patients (Abstract #18172)
MRU data were collected as part of a multinational, randomized trial (STELLAR 4) that compared XYOTAX (n=191) to gemcitabine or vinorelbine (n=190) in patients with advanced NSCLC who had not previously received chemotherapy and who had poor performance status (PS2). MRU and costs associated with chemotherapy administration and non-protocol-driven care were compared over the study period.
The results showed patients on XYOTAX had longer median survival (220 days vs. 198 days; p=0.686) with significantly fewer adverse events (all grades; 2.0 vs. 3.0; p=0.011), despite receiving more chemotherapy cycles (3.9 vs. 3.4; p=0.007). In addition, XYOTAX patients had fewer outpatient visits (0.6 vs. 1.7; p < 0.001), required fewer diagnostic tests (0.6 vs. 1.9; p < 0.001), and were on non-chemotherapy medications for a shorter period of time (64.4 days vs. 91.2 days; p < 0.001). The difference in the number of hospitalizations or length of hospital stays was not statistically significant.
The total average cost of treatment reported, excluding drug costs, was lower for XYOTAX patients ($2,518 per patient) than patients on the control arm ($4,834 per patient). Costs included outpatient visits ($34 vs. $78; p=0.014), non-chemotherapy medications ($717 vs. $911; p < 0.001), chemotherapy administration ($1,557 vs. $3,601; p < 0.001), and in-patient stays ($210 vs. $244; p=0.794) per patient.
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. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. 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. 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(TM) 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 more cost 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.
Source: Cell Therapeutics
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