The world’s countries differ in
countless ways, but are similar in that they shoulder the task of protecting
the health of their citizens. While the biggest health threats faced by
emerging nations are communicable diseases such as HIV/AIDS, malaria and
tuberculosis, these nations are also documenting rises in non-communicable
disease such as cancer, diabetes and inflammatory disease. If drugs are
available, many are hinged with high cost, complex administration and storage,
significant side effects, or other challenges that prevent mass usage.
With decades of research behind
it, naltrexone, or Lodonal™ as it is known internationally, is gaining global
traction as a non-toxic, affordable and easy-to-administer therapy for both
communicable and non-communicable diseases.
The U.S. FDA approved naltrexone
50 mg for the management of alcohol and opioid dependence in 1984; since then,
many doctors in the United States have also prescribed low-dose naltrexone
(LDN) to treat a number of indications, including multiple sclerosis (MS),
Parkinson’s disease, Crohn’s disease, HIV/AIDS, cancer and other autoimmune and
inflammatory diseases. While the mechanism of naltrexone in autoimmune diseases
and cancer is still being researched, researchers have theories as to why LDN
works on autoimmune diseases, cancer and inflammatory diseases.
In short, Lodonal/LDN helps the
body heal itself by increasing the levels of endorphins (peptides produced in
the brain and adrenal glands), which serve as powerful modulators of the body’s
immune system. Lodonal attaches to opioid receptors in the brain and immune
cells, temporarily blocking endorphins signals and causing the body to increase
endorphin production. This boost of endorphin production helps facilitate the
activity of stem cells, macrophages, natural killer cells, T and B cells and
other immune cells. Lodonal also prevents immune system over activity, the crux
of autoimmune disorders, and blunts the release of inflammatory and neurotoxic
chemicals in the brain.
So how effective is LDN in such a
wide range of indications? That’s what Orlando, Florida-based Immune
Therapeutics, Inc. (OTCQB: IMUN) aims to find out. Immune Therapeutics has
built a technology platform using patented immunotherapy to combat chronic,
life-threatening diseases by activating and modulating the body’s immune system
to enhance treatment.
The company’s most advanced
clinical programs involve immunotherapy with met-enkephalin (MENK) and LDN, the
latter of which the company is pursuing in additional investigations as a
viable treatment for autoimmune conditions such as rheumatoid arthritis and MS;
as an adjunct in cancer patients undergoing chemotherapy, radiation treatments
or surgery; and as a complement to antibiotics in the treatment of a variety of
infectious diseases, including patients with HIV/AIDS, in combination with
retroviral drug therapy.
In collaboration with AHAR Pharma and
GB Pharma Holdings, Immune Therapeutics recently completed a bridging trial
comprised of HIV-positive patients to confirm the safety and efficacy of
Lodonal. Resulting data was submitted to Nigeria’s National Agency for Food and
Drug Administration Control (NAFDAC) in connection with approval of Lodonal as
an immune booster to improve health of those affected by HIV-positive status
and others with compromised immune systems.
This milestone is of particular
importance in sub-Sharan Africa, where an estimated 24.7 million people – 71%
of the global total – live with HIV. Ten countries account for 81% of all
people living with HIV in the region, and 50% of those live in Nigeria and
South Africa. Additionally, Immune Therapeutics reports that 80% of people who
do not have access to HIV treatment are in Nigeria, which adds weight to the
fact that Lodonal can provide non-toxic stand alone or adjunct treatment for
less than $0.90 a day.
For more information on the
specifics of the trial, visit
https://www.immunetherapeutics.com/wp-content/uploads/2016/01/Lodonal_Bridging_Trial.pdf
In a news release announcing the
completion, Dr. Nicholas Plotnikoff, Immune Therapeutics’ non-executive
chairman, said, “We are excited about achieving this major milestone in
collaboration with our partner organizations AHAR Pharma and GB Pharma
Holdings. The shortened time frame of the Lodonal™ submission was facilitated
by professionalism and thoroughness from NAFDAC. We look forward to continued
cooperation with NAFDAC in the review of Lodonal™ in the hope of making a
general immune booster and adjunct treatment for HIV+ patients.”
As part of this process, Immune
Therapeutics in August 2015 signed a Letter of Intent with leading Nigerian
pharmaceutical company Fidson Healthcare PLC for exclusive distribution rights
in Nigeria and expects to finalize the agreement upon final NAFDAC approval for
Lodonal.
HIV/AIDS remains one of three
global public health threats, and, standing at the brink and waiting for NAFDAC
approval for something with incredible potential to address this health
concern, Immune Therapeutics continues to advance its pipeline for oncology and
immunology – with LDN in phase 3 studies for MS, Chron’s UC and fibromyalgia
and phase 2 studies for advanced cancers and HIV.
For more information visit www.immunetherapeutics.com
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