Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has recently approved its Immune Therapeutics, Inc. patented Lodonal™ as an over the counter, non-toxic adjunct therapy in the treatment of HIV/AIDS and immune system regulator.
The receipt of NAFDAC’s approval will enable the Company’s distribution partner, AHAR Pharma (include link), and GB Pharma Holdings (include link), to launch a nationwide marketing and sales program that is expected to generate new and significant revenue channels for the Company.
The NAFDAC approval follows the successful completion of a 90-day bridging study conducted by AHAR Pharma on behalf of the Company in conjunction with State Specialist Hospital in Asubiaro. That study, “A Bridging Study to Evaluate the Effects of ‘Lodonal’ as an Immune-System regulating Agent in Subjects in which Their Immune System is Compromised: Lodonal in the Treatment of Subjects with Human Immuno-Deficiency virus (HIV),” met the primary and secondary endpoints for both efficacy and safety.
The 90-Day Bridging Study was undertaken at the State Specialist Hospital in Asubiaro, Osogbo, Osun State, Nigeria and the primary objective of this Bridging trial was to confirm that Lodonal had a beneficial effect on the immune system of immune deficient patients and safety. This was a single center, open labeled, randomized, bridging study of a 150 people. The Treatment Group was treated with 4.5 mg of Lodonal nightly in conjunction with antiretroviral. The Control Group was treated with antiretroviral plus placebo. The primary endpoints were efficacy and safety determined by a minimum increase of 25% in the CD4 count with no adverse effects on quality of life.
The results yielded an average 44% increase in CD4 count in the Treatment Group compared with 11% increase for the Control Group and there was no adverse effect on quality of life or opportunistic infections during the trial. The Nigeria trial’s results were consistent with previous clinical trials of LDN.
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