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
