FDA approves Energex Systems non-drug therapy for HIV research

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 virus's 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 virus's ability to develop resistance and mutate, current drug therapies have only been able to partially stem the tide against HIV's 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 patient's 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 company's 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.