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Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway

SEATTLE, Aug. 22 /PRNewswire-FirstCall/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC), today announced they have entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) of the National Institutes of Health (NIH). The goal of this CRADA is to develop patented products for the treatment of patients with cancer -- specifically, human monoclonal antibodies (hmAbs), peptides, and small molecules that affect signal transduction through the insulin-like growth factor (IGF) receptor type I (IGF-IR) and the insulin receptor (IR).

Under terms of the CRADA, which is effective for five years beginning July 31, 2007, SM will have an exclusive option to elect an exclusive or non- exclusive commercialization license to any inventions developed under the CRADA. Scientists at SM and CTI will work with scientists at the Protein Interaction Group at the NCI campus in Frederick, Maryland.

"This is important research being conducted by leaders in the field at NCI that may offer advantages over other therapeutics directed at this target. If successful, CTI would have exclusive rights to negotiate with NIH for a product that targets the ligand that activates the IGF receptor, unlike current approaches to IGF inhibition that target the receptor directly," said James A. Bianco, M.D., President and CEO of Cell Therapeutics, Inc. "This is another exciting addition to several early stage targeted therapies we are evaluating including SRC inhibitors and bisplatinates."

Daniel D. Von Hoff, M.D., Chief Medical Advisor to SM, Physician-in-Chief and Director of the Clinical Translational Research Division at the Translational Genomics Research Institute in Phoenix, Arizona and head of CTI's strategic product portfolio committee noted that, "the IGF system plays an important role in many physiological processes, especially in pathological conditions such as cancer. We were impressed with the data, the results and the potential advantages of the totally human antibody to IGF-II initially reported by Dr. Dimitrov in the January 2006 issue of Molecular Cancer Therapeutics. We contacted Dr. Dimitrov, evaluated the opportunity and entered into this CRADA."

Dimiter S. Dimitrov, Ph.D., NCI principal investigator for the CRADA and head of the Protein Interaction Group of the CCR Nanobiology Program at the NCI's Center for Cancer Research, will lead the research effort. Dimitrov's group is focused on the development of fully human monoclonal antibodies targeting the IGF pathway and system in the search for novel cancer therapeutics. Recently published data and ongoing research and development validate IGF as a promising target for the treatment of patients with cancer. Dimitrov's laboratory has filed patent applications for a panel of novel human antibodies against components of the IGF system, including IGF-II and IGF-I.

"Recently several antibodies targeting IGF-IR have entered clinical trials. Antibodies that target only the receptor could bind to normal cells expressing the receptor with possible toxic effects. Thus, our initial focus will be on antibodies against the ligands IGF-I and IGF-II that inhibit interaction with IGF-IR," said Jack W. Singer, M.D., Chief Medical Officer at CTI. "Early data has been submitted from this CRADA research for presentation at the upcoming AACR-NCI-EORTC meeting in October."

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

About Systems Medicine (SM)

In July 2007, CTI acquired SM, a privately held oncology company, in a stock for stock merger. Systems Medicine (SM) applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical, and regulatory expertise to find and exploit a specific cancer's 'context-of-vulnerability.' Specifically, SM defines the molecular and genetic alterations (context) that cause cancer cells to be particularly sensitive (vulnerable) to a drug or combination of drugs-the 'context-of-vulnerability'.

About the National Cancer Institute's Center for Cancer Research Nanobiology Program

The National Cancer Institute (NCI), part of the NIH, an agency under the U.S. Department of Health and Human Services, is the world's pre-eminent cancer research organization. The NCI engages in certain fundamental activities which include: conducting and fostering cancer research; reviewing and approving grant-in-aid applications to support promising research projects on the causes, prevention, diagnosis, and treatment of cancer; collecting, analyzing, and disseminating the results of cancer research conducted in the United States and elsewhere; and training and instruction in the diagnosis and treatment of cancer. The Center for Cancer Research Nanobiology Program (CCRNP) serves as a catalyst to move forward multidisciplinary efforts in the area of Cancer Nanotechnology. The program forms partnerships with the NCI's broader Nanotechnology Program, other CCR basic research laboratories and clinical branches, as well as with the broader extramural community, to enhance the interface of physics and computational sciences with biology.

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 success of developments realized by SM under the CRADA, SM's ability to successfully negotiate for the rights to further develop, market and sell any products that are developed under the CRADA on terms that are favorable to SM and CTI, and SM's ability to realize potential benefits of any such products include risks associated with research and development in the biopharmaceutical industry in general and with the risks associated with development, protection and enforcement of intellectual property rights arising under the CRADA. In particular, these risks include, without limitation, the potential failure of SM and NCI/NHI to develop anything of significant commercial value under the CRADA or to develop any products that prove safe and effective for treatment of cancer by targeting the insulin growth factor pathway, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling any marketable products, including patentable products, that are developed under the CRADA and owned by or licensed to SM for further development, marketing and sale, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, neither CTI nor SM is under any 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.

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Susan Callahan

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Investors Contact:

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SOURCE Cell Therapeutics, Inc.
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