Researchers to evaluate potential of new drug combined with standard chemotherapy in treatment of stage III ovarian cancer

May 01, 2001

SEATTLE - The University of Washington and Fred Hutchinson Cancer Research Center's Puget Sound Oncology Consortium will lead a nationwide phase II clinical trial evaluating the safety and effectiveness of combining standard initial chemotherapy (paclitaxel and carboplatin) with IM862, a peptide that appears to have cancer fighting properties. Preclinical research suggests that IM862 stimulates the body's immune system and inhibits the development of blood vessels (angiogenesis) needed by tumors to grow and metastasize. Patients can self-administer the drug as nose drops and it is absorbed into the bloodstream through the mucous membranes. To date, IM862 has been tested in clinical trials involving over 400 cancer patients and has demonstrated a favorable safety profile with generally mild side effects.

Approximately 27,000 new cases of ovarian cancer are detected each year in this country and some 15,000 women die annually from the disease. Because no reliable means of early detection exists, most cases are not diagnosed before they reach an advanced stage. The majority of women with stage III ovarian cancer initially achieve complete remission with surgery and standard chemotherapy. However, many patients relapse with time.

Drs. Pamela J. Paley, a gynecological oncologist at the University of Washington and Leona A. Holmberg, a medical oncologist at Fred Hutchinson Cancer Research Center, will lead the nationwide study. According to the researchers, adding IM862 to standard chemotherapy as initial therapy may have real potential.

"Due to its apparent immune stimulating and angiogenesis inhibiting properties, the addition of IM862 may reduce blood vessels that feed tumor cells, as well as increase the ability of the patient's own immune system to kill their cancer. Our hope is that the combination of IM862 and chemotherapy will result in a larger number of women with ovarian cancer achieving long term remission from their disease with little or no additional toxicity," said Dr. Paley.

The multi-center trial will involve 180 women with stage III ovarian cancer at fifteen medical centers across the United States. Study sites are located in Seattle, St. Louis, Chapel Hill, N.C.; Minneapolis; Omaha, Neb.; Los Angeles; Buffalo, N.Y.; Burlington, Vt.; Madison, Wis.; Cleveland, Washington, D.C.; Pittsburgh; Columbus, Ohio; Las Vegas, Nev.; Atlanta, Ga.; and Palo Alto, Calif. Women eligible for the study must be 18 years or older and newly diagnosed with stage III ovarian cancer who have undergone optimal surgery for removal of their tumor and not received prior treatment for their cancer. Patients will be randomized to one of three arms of the study, each with a different dose of IM862 while undergoing conventional treatment of six cycles of chemotherapy (paclitaxel and carboplatin). Following combined treatment of chemotherapy and IM862, "second look surgery" will be performed to assess presence of disease. Patients with no evidence of disease or with only microscopically detectable residual disease will be treated with IM862 for an additional 24 weeks. The trial is double-blinded so neither patient nor physician will know which dose of study drug the patient is receiving.

The study's primary objective is to determine the safety of IM862 when it is given with chemotherapy as well as if the addition of IM862 increases the percentage of patients with no evidence of disease at second look surgery. Historically, approximately half of patients show evidence of disease at that time. Secondary objectives include evaluation of occurrence of infection or other complications, length of remission and the ability of IM862 to decrease tumor blood supply and stimulate the immune system. IM862, developed by Cytran, Inc. of Kirkland, Wash., is a synthesized version of a naturally occurring small peptide.
-end-
For more information on the study, contact Dr. Paley at 206-543-3669, Cytran at 877-449-4692 or visit the Cytran web site at www.cytran.com.

The Fred Hutchinson Cancer Research Center is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's four scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. For more information, visit the Center's Web site at www.fhcrc.org

The University of Washington's faculty includes four Nobel Prize-winners, five MacArthur Fellows, and 39 members of the prestigious National Academy of Sciences. Its highly regarded School of Medicine has been ranked (by U.S. News & World Report) first in the nation in training primary-care physicians, and several of its graduate and professional programs are rated among the top 10 in their fields. Since 1975, the UW has been the nation's top public university in receipt of federal research funds, and since 1992 it has been second among all U.S. universities, public and private.

Cytran, Inc. is a privately held biopharmaceutical company, developing and commercializing drugs that fight cancer through stimulating immune system response and inhibiting angiogenesis. In addition to ovarian cancer, IM862 is currently being evaluated for use in treating patients with AIDS-associated Kaposi's sarcoma, prostate, breast and colorectal cancers.

Nationwide, multi-center clinical trial to be led by the University of Washington and Fred Hutchinson Cancer Research Center's Puget Sound Oncology Consortium

Dr. Pam Paley and Katherine White, the first patient enrolled on the study, are available for interviews. Please call Susan Edmonds to arrange an interview.

Fred Hutchinson Cancer Research Center

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