Energex System's Non-Pharmicalogical Treatment Shown to Be Effective in Stimulating Immune System and Reducing Viral Load in HIV/AIDS Animal Model.

EMERSON, N.J. -- Energex Systems, Inc. announced today that results of a clinical trial on rhesus macaque monkeys infected with the Simian Immunodeficiency Virus (SIV) established that the Company's ultraviolet light technology was safe and effective in increasing cell mediated immunity against the virus and in reducing viral load.

SIV infection of rhesus macaque monkeys is the most widely accepted animal model for in vivo studies of immune responses and clinical progression to AIDS. The basis for this acceptance is that SIV infects the same types of cells as found in HIV infected humans and the clinical AIDS that develops is the same as that seen in the human disease. This animal model is a particularly stringent test for immunotherapies, even more so than HIV in humans. The viral loads in SIV infected monkeys are generally higher compared to HIV infections in humans. Moreover, AIDS develops in less than five years compared to a 7 to 12 year course in untreated humans. SIV is also profoundly immunosuppressive so that any changes in immunity against the virus would be viewed as highly significant.

The animal model was used in this study to test for immune stimulation after treatment with the Energex Hemo-Modulator (HM). The HM is an extracorporeal device capable of treating whole blood with UV irradiation and re-infusing the treated blood. The hypothesis is that UV-inactivated SIV will serve as an autologous vaccine and boost the immune system of infected humans against their own strain of virus.

Energex's experimental treatment involves exposing a very small amount of an infected subject's blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Thomas Petrie, the developer of the technology and Director of Engineering at Energex Systems. "During exposure, any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The result, we believe, as evidenced by these trial results, is a stimulation of the immune system and a reduction in viral load," said Petrie. The process takes 20-30 minutes. An animation of the procedure can be viewed at http://www.energexsystems.com/hemomod.htm.

In the trial, three rhesus monkeys were infected with SIV. One monkey received 5 treatments between 13 and 16 weeks post-infection, while the other two received 7 treatments between weeks 51 and 55. This strategy allowed for treatment at times representing early and late infection, respectively. The immunological assay used was ELISPOT, a measure of cell-mediated immunity. The measure of clinical progression was bDNA. bDNA measures the amount of virus in the blood and is a key marker for progression to AIDS.

The two monkeys treated with 7 treatments between the 51st and 55th week post infection showed an increase in cell-mediated immunity against the virus. This increase was detected shortly after the treatments. Concomitant with this boost in immunity was a significant decrease, 4-5 fold, in plasma viral load. No deleterious effects were observed that could be associated with treatment. There was weight loss during the treatment, however weights returned to normal after treatment. All blood work data were consistent with SIV infection and were not attributed to the treatments. The 3rd monkey treated 5 times between the 13th and 16th week did not show a change in viral load. The results of ELISPOT tests to determine if there was cell-mediated immunity in the 3rd monkey are in progress.

"When coupled with the recent results of our human Hepatitis C trial that also established similar reductions in viral loads, and no adverse events, I believe this technology and the treatment it provides should be considered extremely promising in the fight against HIV/AIDS, Hepatitis C and other RNA type viruses," said Thomas J. Fagan, President of Energex Systems. "We are excited about the potential that this technology has to manage these hard-to-treat diseases, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from them. We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for these potentially life threatening diseases," said Fagan.

Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care.