To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AACR-EORTC-NCI: PG-TXL (CT-2103) Shrinks Tumors in Late-Stage, Previously Unresponsive Cancer URL: http://www.pslgroup.com/dg/20C692.htm Doctor's Guide October 31, 2001
SEATTLE, WA -- October 31, 2001 -- Preliminary results of two clinical trials have demonstrated that PG-TXL (CT-2103), given alone or in combination with cisplatin, shrinks tumors in patients with advanced cancer who have failed standard treatments. Historically, very few patients with recurrent cancer who are treated with standard chemotherapies typically respond.
PG-TXL was well tolerated and rarely caused serious drug-related side effects. The study results were presented at the 2001 American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AACR-EORTC-NCI) International Conference in Miami. PG-TXL is Cell Therapeutics, Inc.'s (CTI's) investigational anti-cancer product.
"The finding that PG-TXL shrinks tumors in patients with advanced cancer who have not responded to other chemotherapies, including Taxol, is exciting because few of these patients typically respond to treatment, and they often experience severe side effects," said Mary G. Bolton, M.D., Ph.D., director, clinical development and project team leader for PG-TXL at CTI. "To date, more than 120 patients have been treated with PG-TXL, and trials are continuing to enroll patients rapidly." Dr. Bolton added that patients on PG-TXL experience very few side effects (e.g., minimal hair loss, infrequent mild neuropathy, minimal nausea). No patient has required dose modification.
One of the studies, a phase I/II multi-center trial, is being conducted to evaluate the safety, tolerability and anti-tumor activity (as defined by response rate and time to progression) of PG-TXL. Twenty-nine patients with recurrent ovarian or peritoneal cancer who had experienced progressive disease following two prior chemotherapy regimens and who had received prior paclitaxel were treated with PG-TXL as a 10-minute intravenous infusion every 21 days.
Twelve of the 29 patients are being studied at Memorial Sloan-Kettering Cancer Center in New York City. Of those 12 patients, nine are evaluable for response. Four of the nine patients have demonstrated a response: two with confirmed partial response and two with stable disease.
"These anti-tumor results suggest that PG-TXL may have a favorable impact on tumor progression among patients with recurrent ovarian or peritoneal cancer, many of whom were heavily pre-treated," said Paul Sabbatini, M.D., the principal investigator for the study and assistant attending physician in the Department of Medicine, Developmental Chemotherapy Service and Gynecological Oncology Service at Memorial Sloan-Kettering Cancer Center.
In the study, PG-TXL was well tolerated. No drug-related serious adverse events have been reported in patients who received at least one cycle of treatment, and no dose-limiting toxicities have occurred in any patients. Hypersensitivity reactions have occurred infrequently, have been easily treated with standard medications and have not resulted in discontinuation of therapy. Minimal alopecia (hair loss) and mild neuropathy have been observed in an occasional patient.
The other trial, a phase I study being conducted at The University of Texas M. D. Anderson Cancer Center in Houston, is evaluating PG-TXL's potential anti-tumor activity and safety in combination with cisplatin. The trial has enrolled seven patients with advanced solid tumors that are refractory to conventional therapy or for which no standard therapy exists. PG-TXL was administered as a 10-minute intravenous infusion followed by a three-hour intravenous infusion of cisplatin every 21 days.
Results have shown that PG-TXL administered in combination with cisplatin shrinks tumors or stops them from progressing in patients with advanced solid tumors. Of the seven patients, three have experienced a partial response (two patients with recurrent ovarian cancer and one patient with recurrent peritoneal cancer) and three have experienced stable disease (one patient each with recurrent endometrial cancer, thyroid cancer and advanced peritoneal cancer). Adverse events were mild to moderate; one patient elected to discontinue chemotherapy after six cycles and a partial response.
PG-TXL is a first-in-class, smart pharmaceutical that links paclitaxel, the active ingredient in Taxol®, to a biodigestable polyglutamate (PG) polymer. This PG technology is designed to selectively deliver higher and potentially more effective levels of active chemotherapeutics to tumors by exploiting the fact that blood vessels in tumor tissues are different than blood vessels in normal tissues in that they are porous to molecules like polyglutamate. Therefore, PG-TXL gets preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. Because more of the chemotherapy is targeted to the tumor and the levels of chemotherapy being delivered to normal tissue are reduced, PG-TXL may be potentially more effective and have less severe side effects than currently available chemotherapeutics.
Clinical studies of PG-TXL have shown that it is well tolerated in cancer patients. It is associated with fewer and less severe toxicities than Taxol when used alone or in combination with other chemotherapeutic agents, including hair loss, nerve damage, infection risk, and nausea and vomiting.
PG-TXL can be administered in a rapid 10-minute infusion. Because of its convenient administration and reduced toxicity, it is expected to be associated with an improvement in quality of life for cancer patients.
SOURCE: Cell Therapeutics, Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.