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REMUNE: A RETURN OF HOPE?

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Date: 18 Nov 2007
Time: 09:59:50

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Date: 15 Jun 2001
Time: 08:28:47

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The previous failure of REMUNE’s European and U.S. trials’ results to show a significant efficacy as a biological treatment in HIV infection studies could be due to a confusion resulting from the use of the vaccine in combination with conventional anti HIV treatments.

REMUNE is biological treatment for AIDS developed by IMMUNE RESPONSE and licensed to Trinity Medical Group (TMGU)

This conclusion was made based on data presented at the Eleventh Symposium of HIV Infection, held in Toulon, France. The data presented concluded that near two thirds of infected patients with HIV might have benefited from REMUNE when it was administered alone. In addition, the treatment remained safe after a long-term use.

Administered alone, REMUNE resulted in increased CD4 and CD8 T cell count and body weight.

THE STORY

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.

After week 40, the entire study group was placed on IBT and the study continued in unblinded fashion. At 132 weeks, 223 patients remained in the study with REMUNE AS THE SOLE 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.

Concluded also was the fact that the response to Immune Based Therapy (IBT), such as REMUNE, appears to depend upon the person's immune system’s condition. 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 use of other antiviral drugs, in addition to REMUNE

Based on the aforementioned results and facts, REMUNE might be a good treatment option in third world countries where conventional antiviral drugs are too expensive. IBT, such as REMUNE, is expected to be much more affordable.

REMUNE injections are administered quarterly - a regimen that can be well tolerated and simpler to administer.

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.

TRINITY MEDICAL GROUP (TGMU)

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.

Trinity Medical Group USA announced 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.

DISCLAIMER

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.

Prohost Comments

The conclusions above confirmed our understanding that the results of biological immunotherapies, including vaccines cannot be relied on when reviewed early in the course of treatment.

The results of the trials that used REMUNE alone taught us also that, in some diseases, the results of trials with an experimental drug in combination with conventional fairly effective drugs could be misleading. At an early stage, conventional drugs look extremely effective. This effect declines as time goes by and after the experimental drug to be evaluated is condemned. The reason for the confusion is that the addition of the experimental drug to the conventional drugs would not provide better figures than the excellent ones provided by the current treatments. Used alone, however, the source of efficacy becomes easy to recognize.

 




 

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