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Camptothecin Polymer Conjugate, CT-2106, Advances to Phase II Clinical Trials

SEATTLE, June 10 /PRNewswire-FirstCall/ -- Following a review of initial phase I clinical trial safety and pharmacokinetic data at pre-specified doses in an ongoing clinical trial, Cell Therapeutics, Inc. (CTI) (NASDAQ:CTIC) is advancing the clinical development of its novel camptothecin polymer conjugate (CT-2106). In early 2004, the Company anticipates initiating phase I and II studies of CT-2106 in combination with standard chemotherapy in colorectal cancer and as a single agent in small cell lung cancer. Camptothecins are one of the world's fastest growing classes of anti-cancer agents. Commonly used as treatment for colorectal, lung and ovarian cancer, camptothecins are limited by their severe side effects.

CT-2106 links 20S-camptothecin to CTI's polyglutamate polymer, creating the second agent in the company's portfolio to exploit the novel delivery technology. In the ongoing phase I study, CT-2106 was administered over a 10-minute infusion at escalating doses in groups of three to six patients with a variety of advanced stage cancers. A total of 13 patients have been studied and no severe toxicities have been reported to date.

The naturally occurring product, 20S-camptothecin is among the most potent compounds in this class of agents and was evaluated in phase I and II trials by the National Cancer Institute but its development was discontinued due to severe side effects. It was later learned that when 20S-camptothecin was administered to a patient, it converted to an inactive and potentially toxic metabolite by binding to a common human serum protein.

"Based on preliminary results of the ongoing phase I study of CT-2106, we believe that we will be able to administer 20S-camptothecin in its active form in tumors without observing the severe side effects previously reported for this agent," stated Jack W. Singer M.D., EVP and Research Chair at CTI. "The decision to move forward with the clinical development of CT-2106 represents an important milestone for our polyglutamate technology."

About CT-2106
CT-2106 is the second chemotherapy agent attached to CTI's novel polyglutamate polymer to enter clinical trials. In preclinical models, the PG 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 one of the fastest growing groups of commercially available anticancer agents.

Source: Cell Therapeutics, Inc.

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