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Clinical Data of REMUNE as Long Term Immune Based Therapy of


RANCHO SANTA MARGARITA, Calif., June 15 /PRNewswire/ -- Trinity Medical Group USA, Inc. (OTC Bulletin Board: TMGU) announced today the presentation of clinical data of HIV positive patients who have undergone treatment using its Immune Based REMUNE product. The presentation concludes that long term REMUNE treatment is safe and resulted in increased CD4 and CD8 T cell count and body weight. These patients were not receiving any other form of antiviral therapy.

The data were presented at the Eleventh Symposium of HIV Infection, held in Toulon, France.

"The data suggest that nearly two thirds (65.91%) of infected patients could benefit from REMUNE as the sole treatment for HIV. The response to Immune Based Therapy (IBT), such as REMUNE, appears to depend upon the state of a person's immune system; if the immune system has not degraded below a certain level, for example as measured by CD4 and viral load, the probability of benefit from IBT increases. On the other hand, if a person's immune system is below a threshold level, the appropriate course of action may be the judicious use of other antiviral drugs, in addition to IBT. This suggested course of treatment is vitally important in areas of the world where antiviral drugs are not easily obtainable and rationing is required," says Dr. Vina Churdboonchart, President of Trinity Medical Group USA, Inc.

Conventional antiviral therapy in the U.S. and Europe may cost $10,000 to $20,000 annually. In countries such as Thailand, where the average income is on the order of several thousand dollars per year, conventional antiviral therapy is out of reach for many. IBT, such as REMUNE, is expected to be much more affordable. The course of treatment using REMUNE consists of a quarterly injection with no adverse side effects; such a regimen should be well tolerated and simpler to administer.

The original study group consisted of 297 HIV positive patients. The results of study after 40 weeks, which included a placebo control group, was previously announced by the Company in October of 2000 and published in the journal Clinical and Diagnostic Laboratory Immunology in September of 2000. The entire study group was placed on IBT after week 40 and the study continued in unblinded fashion. At 132 weeks, 223 patients remained in the study with REMUNE as the sole antiviral treatment. The data suggest the study group can be subdivided into responder and non-responder classes, as measured by CD4 and CD8 cell count increases or decreases, respectively. The responder group consisted of 147 patients or 65.91% of the total. CD4 and CD8 cell counts for the responder class increased an average of 164 and 543 cell counts per micro liter, respectively, after 132 weeks.

The studies of REMUNE conducted by Trinity USA and its affiliates in Thailand are currently the only ones in which no other antiviral drug is used by the patients. In studies of REMUNE conducted in the U.S. and Europe, the concomitant use of REMUNE and other antivirals may have contributed to lack of significant findings of efficacy for REMUNE in the early stages of those studies. "Monotherapy using REMUNE may become a practical solution in developing nations. Our studies continue to show promise at an earlier time frame perhaps due to our study conditions of monotherapy. Our studies are zeroing in on a precise course of treatment for the majority of patients," says Dr. James Namnath, CEO of Trinity Medical Group USA, Inc.


Trinity Medical Group USA is also pleased to announce that its common shares of stock are now listed for trading on the Over the Counter Bulletin Board under the ticker symbol TMGU. On some information systems, current quotes may be retrieved using the TMGU or TMGU.OB ticker symbols.

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.

Trinity Medical Group USA, Inc. is a developmental stage company. The Company's common stock is currently listed on the Over the Counter Bulletin Board 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 study in Thailand. REMUNE is a product licensed from The Immune Response Corporation of Carlsbad, California (Nasdaq: IMNR). REMUNE is a trademark of The Immune Response Corporation.

CONTACT: Trinity Medical Group USA, Inc. investor relations, 303-369-7128, or; Web site:

SOURCE Trinity Medical Group USA, Inc.

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Information in this article was accurate in June 15, 2001. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.