ATLANTA, June 5 /PRNewswire-FirstCall/ -- At the 2006 Annual Meeting of the American Society of Clinical Oncology (ASCO), preliminary data from Cell Therapeutics, Inc.'s (CTI) phase I study of CT-2106, a novel polyglutamate-camptothecin conjugate for patients with advanced solid tumor malignancies were presented. The study showed that dosing weekly for three consecutive weeks every 28 days resulted in a dose intensity similar to that seen with dosing once every 21 days. In the 19 patients studied, CT-2106 was generally well-tolerated, without the toxicities normally associated with camptothecin (CPT), specifically hemorrhagic cystitis and severe diarrhea. The maximum tolerated dose (MTD) was 25-35 mg/m2 in these heavily pretreated patients. Dose limiting toxicities were thrombocytopenia and fatigue.
The primary objective of the study was to determine the MTD of CT-2106 when administered weekly for three consecutive weeks on a four-week cycle. Secondary objectives are to evaluate the safety, pharmacokinetics of CT-2106, and to assess disease response.
“This novel polyglutamate-camptothecin conjugate appeared to be well tolerated, with reduced bladder toxicities that characterize the parent camptothecin molecule,” said Adil Daud, M.D., Medical Director of Affiliate Research, H. Lee Moffitt Cancer Center and Research Institute. “Weekly treatment with CT-2106 should be further explored in a variety of contexts.”
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About the Study
The single-center study was conducted at H. Lee Moffitt Cancer Center in Tampa, Florida. It was an open-label, dose-escalation study. CT-2106 was administered at doses of 25, 30, or 35 mg/m2 over 10 minutes on days 1, 8, and 15 of a 28-day cycle.
About CT-2106 (polyglutamate camptothecin)
CT-2106, a camptothesin attached to CTI’s novel polyglutamate polymer, is in phase I/II clinical trials. In preclinical models, the polyglutamate technology appears to be capable of delivering more chemotherapy directly to the tumor, making each dose potentially more effective without increasing side effects. Camptothecins are an important product class of cancer fighting compounds used for colon and lung cancer and are notably the second fastest growing group of commercially available anticancer agents.
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 CT-2106 include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with CT-2106 in particular including, without limitation, the potential failure of CT-2106 to prove safe and effective for treatment of solid tumor malignancies, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling CT- 2106, 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.
Cell Therapeutics, Inc.
CONTACT: investors, Leah Grant, +1-206-282-7100, or fax, +1-206-272-4434,or invest@ctiseattle.com, or media, Susan Callahan, +1-206-272-4472, orfax, +1-206-272-4434, or media@ctiseattle.com, both of Cell Therapeutics,Inc.
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