AEGiS-PRn: Trinity Medical Group USA Announces Continuation of HIV Clinical Trial

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

Trinity Medical Group USA Announces Continuation of HIV Clinical Trial

PRnewswire - Monday November 13, 2000

SAN RAFAEL, Calif., Nov. 13 /PRNewswire/ -- The Clinical Trial using REMUNE(TM) as a treatment for HIV in Thailand has been approved for an additional two years. The Study, known as Protocol 2101B, will become one of the longest scientific examinations of Immune Based Therapy (IBT) for humans infected with HIV. The approval by two national committees of the Thai government was made with supporting requests from the attending physicians and patients for continued access to REMUNE. With these approvals, patients in the study can continue to receive REMUNE treatment. Results of the study continuation are not required by the Thai FDA in their consideration of REMUNE for commercialization.

"We are encouraged by the support and desire by the study participants and attending physicians to continue to have access to REMUNE in their battle against HIV. Many patients are now well into their third year of treatment. We will be getting highly detailed and long-term results of this study, of up to five years of REMUNE treatment, for future analysis," says Dr. Vina Churdboonchart, who is principal investigator for the study.

REMUNE is the leading IBT product in human clinical studies around the world for the treatment of HIV. IBT relies upon the infected individual's own immune system to ward off progression of the disease as opposed to conventional drug therapy which may have adverse side effects and may become less effective due to viral mutation. REMUNE is a result of the scientific collaboration between the late Dr. Jonas Salk, the renowned creator of the world's first Polio vaccine, and The Immune Response Corporation which licenses and manufactures REMUNE.

The Clinical Trial originally enrolled 297 volunteers from five university hospitals (33 volunteers in each of the 9 cohorts), with dosing at 2:1 ratio REMUNE to placebo (control group). The study results at 40 weeks were the subject of five presentations at scientific conferences and a publication in the September 2000 issue of the Journal "Clinical and Diagnostic Laboratory Immunology". After 40 weeks, all patients received REMUNE. To date, approximately 88% of the study group remain on treatment using REMUNE, almost all of whom are not taking any additional anti-viral drugs. A subset of the study group will receive supplemental treatment using additional therapies after Week 148. Some study participants have now surpassed 160 weeks of treatment using REMUNE as the sole therapy.

The study extension was approved by two national committees of the Thai government, The Technical Subcommittee on AIDS Vaccine Development and the National Ethical Committee, Ministry of Public Health.

The Immune Response Corporation has agreed to continue to supply REMUNE for this study. Trinity Medical Group USA will also continue to financially and administratively support this continuing study.

This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether additional clinical trials will be successfully concluded and whether REMUNE will be approved for marketing or be successfully commercialized.

For more information on the Company, visit the web site at http://www.trinitymg.com

Trinity Medical Group USA, Inc. is a developmental stage company. The Company's common stock is listed on the National Quotation Services Pink Sheets under the symbol TMGU. The Company's first product in development is an Immune Based Therapy for the treatment of Human Immunodeficiency Virus (HIV) that has completed Phase II clinical trials and is undergoing further testing in Thailand.

REMUNE is a trademark of The Immune Response Corporation, a Carlsbad California company (Nasdaq: IMNR - news).

For more information on the Company, contact Investor Relations, Trinity Medical Group USA, Inc., 55 Shaver Street Suite 320, San Rafael, CA 94901 (303) 369-7128, email: IR@trinitymg.com.

SOURCE: Trinity Medical Group USA, Inc.

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