AEGiS-PRn: Trinity Medical Group USA Announces Public Availability of REMUNE(TM) Treatment in Thailand

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 Public Availability of REMUNE(TM) Treatment in Thailand

PRNewswire - Wednesday November 15, 2000

SAN RAFAEL, Calif., Nov. 15 /PRNewswire/ -- The first open label availability in Southeast Asia of Immune Based Therapy (IBT) for humans infected with HIV has been approved by the government of Thailand. Up to 10,000 individuals in this program may receive treatment with REMUNE provided they have certain levels of immune system cells (CD4+) and viral loads. Each patient will be analyzed before and during the course of treatment according to a Thai government accepted scientific program known as M903. The open ended program has the potential to gather the most extensive body of data available on the effect of REMUNE used as the only anti-viral therapy and used in combination with other drugs. The ultimate goal of the program is to identify the most beneficial and cost-effective regimen of REMUNE as a treatment for HIV.

Results of this program are not required by the Thai FDA in their consideration of REMUNE for full commercialization and are independent of the Protocol 2101B announced by the Company on November 13, 2000.

"From our previous work, we have seen indications that successful treatment of HIV using REMUNE requires tailoring the course of treatment to the patient's immune system status. While a great many patients respond to the standard treatment dose of REMUNE alone (1 ml. injection once per quarter), others may require additional doses of REMUNE or fortification with other drugs and treatments. We requested, and were granted approval, to have the ability to study the first wave of general public patients in a precise way for the benefit of future recipients of REMUNE," says Dr. Vina Churdboonchart, the Principal Investigator of this program. "We expect the program will be enrolled very quickly."

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 program 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 program will be coordinated through Mahidol University of Bangkok in cooperation with several other University and government operated hospitals.

REMUNE will be exclusively manufactured for the Company by The Immune Response Corporation. Trinity Medical Group USA, Inc., the licensee of REMUNE in Thailand and nine other Southeast Asian Countries, will be the supplier of REMUNE to Mahidol University.

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

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