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FDA Approves Energex Systems, Inc. Non-Drug Therapy For HIV Research

2008-07-14 14:18:00

Novel Approach to Creating Therapeutic Vaccine

ALLENDALE, N.J.–(EMWNews)–Energex Systems, Inc. announced today that it has been granted approval

from the Federal Food and Drug Administration (FDA) to utilize its

experimental HemoModulation therapy in a

clinical trial of HIV infected patients. The purpose of the study will

be to demonstrate safety and monitor viral load changes in patients who

are not yet eligible for antiviral drug therapy.

HIV is a retrovirus that attacks the immune system, destroying or

impairing its function. As the disease progresses, the immune system

becomes weaker, and the person becomes more susceptible to opportunistic

infections. The advanced stage of HIV infection is Acquired

Immunodeficiency Syndrome (AIDS). Globally it is estimated that there

are 33.2 million people living with HIV/AIDS. Currently the only

approved treatments for HIV are drug based therapies that attempt to

reduce viral burden (amount of virus in the blood stream) and the viruss

ability to replicate. The cost and known side effects from these drug

therapies are significant.

Patients living with HIV/AIDS are routinely monitored through blood

tests to provide information about the amount of viral burden and the

health of their immune system (CD4 count). Since it is widely accepted

that lowering viral burden and increasing CD4 counts can reduce disease

progression and delay mortality due to AIDS-opportunistic infections,

current drug therapies for HIV are aimed at reducing viral burden.

However, because of the viruss ability to

develop resistance and mutate, current drug therapies have only been

able to partially stem the tide against HIVs

rapid reproduction and destruction.

Energex Systems HemoModulation

therapy is an extracorporeal treatment that involves exposing a small

amount of an infected subject’s blood (3-4%) to a precise amount of

ultra-violet light (UV), for a precise amount of time. During the

process, any pathogen in the blood that is directly exposed to the UV

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 hypothesis is that UV-inactivated virus will serve as an

autologous vaccine and stimulate the patients

immune system against their own strain of virus. The treatment process

takes 20-30 minutes. An animation of the procedure can be viewed at http://www.energexsystems.com/hemomod.htm.

Our application to the FDA was supported by

the results of two human HCV trials that included over 200 treatments,

as well as the results of a trial that was conducted in rhesus macaque

monkeys infected with the Simian Immunodeficiency Virus (SIV), the most

widely accepted animal model for in vivo studies of immune

responses and therapy effectiveness against the progression of HIV/AIDS

said Thomas Petrie, the companys Director of

Engineering, Research and Development. The

basis for the rhesus macaque model acceptance is that SIV infects the

same types of cells as found in HIV infected humans and the clinical

AIDS that develops in monkeys is the same as that seen in humans. The

monkey model is a particularly stringent test for evaluating

immunotherapies, even more so than HIV in humans. The viral loads of SIV

infected monkeys are generally higher compared to HIV infected humans.

Moreover, AIDS in monkeys develops in less than 5 years compared to a

7-12 year course in untreated humans, said

Petrie.

We believe our HemoModulator technology and

the therapy it provides is extremely promising in the fight against

HIV/AIDS, Hepatitis C and other RNA type viruses,” said Thomas J. Fagan,

CEO & President of Energex Systems. “We are excited about the potential

that it 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 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.

Energex Systems, Inc.
Thomas J. Fagan, 201-995-1919
Fax:

201-995-0095
President & CEO
[email protected]

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