Novel anti-cancer agent shows minimal side effects with preliminary evidence of tumor shrinkage

November 15, 1999

Research results presented at International Conference sponsored jointly by AACR, NCI and EORTC

Washington, DC, November 16, 1999 --- Researchers presented data here today from an ongoing Phase I clinical trial showing that a novel anti-cancer agent, called CCI-779, is well-tolerated and may have antitumor activity. CCI-779 is a derivative of rapamycin, an immunosuppressive agent. Results were presented at the International Conference on Molecular Cancer Therapeutics - Discovery, Development, and Clinical Validation, sponsored by the American Association of Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC).

"By interfering with key proteins that regulate cell growth, CCI-779 may stop the progression of tumors. This is a unique mechanism of action for an anti-cancer agent," explained Eric Raymond, M.D., senior investigator and associate professor of oncology at the Institut Gustave Roussy in Villejuif, France. "If these preliminary results are confirmed in future observations, this may represent a new and safer treatment for cancer patients."

The results were presented by Jerome Alexandre, a physician-in-training and researcher with Dr. Raymond, who received an AACR Young Investigator Scholar Award, bestowed on predoctoral students, postdoctoral fellows, and physicians-in-training for outstanding abstracts. The study is being conducted in collaboration with Axel Hanauske, M.D., Ph.D. from the Oncology Institute in Munich, Germany, and the sponsor Wyeth-Ayerst Research in Radnor, Pennsylvania /Genetics Institute in Munich, Germany.

Twelve patients received CCI-779 in this ongoing Phase I study. Three patients with renal cell cancer experienced tumor regression after other treatments had failed. At the doses used so far, the main adverse effects were mild skin reactions and inflammation of the mucous membranes, which occurred at all dose levels studied, but did not increase in intensity with higher doses or longer duration of treatment.

In cancer cells, there is a loss of control of cell growth and division. CCI-779 appears to block the effect of mTOR, an enzyme that has an important role in regulating the synthesis of proteins that control cell division. Therefore, CCI-779 may stop the production of proteins essential for cancer cell proliferation and possibly survival of cancer cells. According to the researchers, ongoing studies are evaluating other dose levels and longer treatment duration to confirm safety and efficacy of CCI-779 before advancing to Phase II studies to confirm efficacy in several types of cancer.
About The AACR-NCI-EORTC Meeting
Nearly 2,000 leading cancer researchers will share cutting-edge findings at this International Conference.

According to the conference co-chairperson and AACR President Daniel D. Von Hoff, M.D.: "The excitement that surrounds this meeting is an indication of the fast pace at which we are translating basic science into new therapeutic strategies for cancer. We anticipate that the data presented here will move the field forward."

Other research highlights include: The meeting will be held on November 16-19, 1999 at the Washington Hilton Hotel and Towers, Washington, DC. Reporters are required to register in the press room located in the Hilton Hotel's State Room (on the Terrace Level). Press room hours are Monday, November 15 - press registration will take place at 3:00 p.m. to 5:00 p.m.; Tuesday, Wednesday, Thursday, November 16-18; 7:30 a.m. to 5:00 p.m and Friday, November 19; 8:00 a.m. -noon

The AACR is the oldest and largest scientific organization in the world focused on the multi- disciplinary aspects of basic, clinical, and translational cancer research for the prevention and cure of cancer. Its 15,000 members come from 80 countries. The NCI is part of the National Institutes of Health. The EORTC is an international research organization whose goal is to facilitate the transition from experimental discovery into state-of-the-art treatment of cancer. The NCI-EORTC Symposium on New Drugs in Cancer Therapy has been held biennially in Amsterdam for two decades. Under the auspices of these three prestigious organizations, it will now occur annually to help researchers keep up with the rapid pace of discovery in molecular biology and genetics that is identifying new targets for cancer therapeutics.

Cooney Waters Group, Inc.

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