Immune Therapeutics Inc, Announces The Official Publication Announcement of The NAFDAC Approved 90-Day Bridging Trial of Lodonal With HIV/AIDS Patients

Immune Therapeutics Inc (IMUN) "Immune Therapeutics", through its fully owned subsidiary, TNI Biotech International, today announced the dosing of the first patient with Lodonal™ (Once-daily Oral Treatment) for the 90-Day bridging clinical trial of Immune Therapeutics' proprietary patented therapy (Lodonal™) as an adjunct treatment for HIV/AIDS and opportunistic infections. The Bridging Trial has met all parameters of the Nigerian Trial Clinical Research Health [NTCR] & Nigerian Health Research Ethics Committee [NHREC] as confirmed on their official website and stated below: 89519615 A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised. The primary objective of this clinical trial is to confirm that LODONAL has a beneficial effect on the immune system of patients in Nigeria with a compromised immune system (refer to Inclusion/Exclusion Criteria). This will be determined by: The number of subjects with CD4 count stabilization (less than 10% change from baseline mean values) or 25% increase in CD4 counts on LODONAL compared to observation group from baseline to Days 30, 60 and 90. 2015-03-31 http://nctr.nhrec.net/search.php?search=lodonal&submit=Search Dr. Abayomi Oni, Principal Investigator and Lead Consultant on this trial at State Hospital Asubiaro, stated "I am excited about the possibility of Low Dose Naltrexone (Lodonal™) being of immense benefit to our local population of patients with HIV/AIDS in Osun State, Nigeria as has been proven with other populations." AIDS is a chronic, potentially life-threatening condition caused by the human immunodeficiency virus (HIV). By damaging your immune system, HIV interferes with your body's ability to fight the organisms that cause disease. NAFDAC determined that using Lodonal™ as an immune adjunct could provide a tremendous catalyst in enhancing the resistance to the proliferation of HIV/AIDS virus. This 90-Day bridging trial simply provides the verification and legitimization of this precept on this population. Upon completion of this trial, Lodonal™ will be available and could provide positive solutions to millions of HIV/AIDS sufferers. "With the total population in Africa of 1.111 billion (2013) and the incidence and prevalence of HIV and other non-HIV immune compromised states, Lodonal™, being affordable, well tolerated and efficacious in boosting the immune status of individuals at risk is novel and revolutionary. Early deaths due to opportunistic infections would be reduced thereby increasing the labor force in the continent which is essential to the much-awaited economic boom in Africa!" said Dr. Richards Afonja, MD, of American Hospitals and Resorts. The bridging trial for Lodonal™ is a single center 90-Day, double-blind, placebo-controlled trial. The trial has enrolled over 200 patients consisting of a one a day oral treatment with Lodonal™ or placebo, followed by a 60-day open label extension in which all participants will receive Lodonal™. The superiority of Lodonal™ vs. placebo during the double blind period will be evaluated in terms CD4 count (primary endpoint), while key secondary endpoints include the reduction in the number of opportunist infections and improvements in the quality of life measures. "The start of this bridging trial for HIV/AIDS is marking the accomplishment of a critical milestone for Immune Therapeutics," said Noreen Griffin, CEO of Immune Therapeutics. "We are grateful for the opportunity to launch Lodonal™ in Nigeria via this trial, as well as the support we have received from the medical community in Nigeria." There's no cure for HIV/AIDS, but there are medications that can dramatically slow disease progression. These drugs have reduced AIDS deaths in many developed nations. But HIV/AIDS continues to decimate populations worldwide. It is such a devastating health challenge that the US Department of State through its PEPFAR [Presidential Emergency Program for AIDS Recovery] program provides emergency assistance for more than 21 partners, one of which is Nigeria. We believe LDN could be an answer; LDN is safe, easy to administer and affordable. President & CEO GB Pharma Holdings, Dr. Gloria B. Herndon, said " Nigeria has once again assumed its leadership position by undertaking a bridging trial that will allow Lodonal™ to be available to its population and ultimately the rest of Africa. This will revolutionize the concept of health security in Africa by providing an immune booster that offers solutions that are non evasive and reactive. After my forty-five [45] years experience in Africa, this initiative has the potential of being the most far reaching and impactful I have yet to witness.