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 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.
Energex Systems, Inc. 201-995-0095 |
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