Clinical Trial Underway for New Kaposi's Sarcoma Treatment; AIDS Patients with KS Sought in Los Angeles to Participate in Anti-Angiogenesis/Immune Stimulating Drug Research.

Business Editors & Medical Writers

LOS ANGELES--(BUSINESS WIRE)--Dec. 14, 2000

Participants are being sought in Los Angeles to take part in a clinical trial with an experimental cancer drug that can be self-administered as nose drops and has a favorable safety profile.

A total of 200 patients with AIDS-related Kaposi's sarcoma are being sought to participate in a multi-national Phase III randomized, placebo-controlled, double-blinded study of IM862 (developed by Cytran, Inc. of Kirkland, WA).

This study is assessing the safety and efficacy of IM862 and is conducted in collaboration with the AIDS Malignancy Consortium of the National Cancer Institute. U.S. clinical trial sites can be found in: New York, Los Angeles, San Francisco, Seattle, San Diego, Chicago, Boston, Miami, Cleveland, Baltimore, Columbus, Philadelphia, St. Louis, Nashville and Newark. International cities include: Toronto, Vancouver, Montreal, Ottawa, Brussels, Melbourne, and Sydney.

Preclinical research suggests that IM862's anti-cancer properties include inhibition of blood vessel growth (angiogenesis) and stimulation of the immune system. Patients in the trial will be randomized to receive either IM862 or placebo and will self-administer treatments by placing a few drops of IM862 solution or placebo into the nose every other day. Patients will be seen every four weeks for evaluation of response and toxicity. Key patient eligibility criteria include the following: HIV infection, biopsy-proven Kaposi's sarcoma with five or more measurable lesions, patient on stable antiretroviral therapy for at least 8 weeks, and no symptomatic visceral disease. Study duration is six months. Patients on placebo who experience disease progression, or have stable disease at the end of the study, will be offered continued IM862 treatment. Patients who have responded to the first six months of treatment may continue on blinded treatment.

Research has shown that tumors rely on the development of new blood vessels to grow, a process called angiogenesis. Anti-angiogenesis drugs halt the growth of new blood vessels, thus starving the tumors. Preclinical data suggest that IM862 has multiple mechanisms of action including angiogenesis inhibition and stimulation of the body's immune system to attack the tumor. The drug is also being tested in other studies in patients with prostate cancer, colorectal cancer, ovarian cancer and malignant melanoma.

Results of a Phase II trial of IM862 in patients with AIDS-related Kaposi's sarcoma were presented at the 1999 Annual Meeting of the American Society of Clinical Oncology (ASCO) and recently published in the February 2000 issue of the Journal of Clinical Oncology. In that study, 37 percent of patients experienced either a complete or partial response and an additional 48 percent did not have their cancer progress. Average onset of response was 6 weeks after beginning therapy. Complete response was defined as biopsy-proven resolution of Kaposi's sarcoma lesions for four weeks or more without evidence of new disease. Partial response was defined as a reduction in the measurements of 5 target lesions by 50 percent or more, or complete flattening of half or more total lesions. Treatment was well tolerated with minimal side effects.

IM862 is a naturally occurring peptide that is manufactured using conventional pharmaceutical peptide technology. IM862 is readily absorbed into the bloodstream when administered as nose drops. Cytran chose KS for IM862's first indication to demonstrate angiogenesis inhibition because of this malignant tumor's highly vascular nature, and because changes in the tumor are easily observed and measured. KS is a cancer associated with HIV.

Prospective patients should call 800/818-0980 for information on a nearby research site participating in the trial. Information on this study, study sites and enrollment criteria are also available at the AIDS Clinical Trials Information Service, www.actis.org, keyword "IM862", sponsored by the U.S. Food & Drug Administration, the National Institute for Allergy & Infectious Disease, the National Library of Medicine, and the Centers for Disease Control and Prevention.

Cytran, Inc., based near Seattle, is a privately held biopharmaceutical company, developing and commercializing small peptides for the treatment of cancer and other diseases. The Company has an agreement with ALZA Corporation granting marketing rights to IM862 in the United States and Canada.