Biostax Corp (BTAX)

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And from the Nigerian Bridging Trial in 2016...

https://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11337422

IMMUNE THERAPEUTICS RECEIVES NAFDAC APPROVAL FOR LODONAL™
IN NIGERIA: APPROVAL FOLLOWS SUCCESSFUL RECENT BRIDGING STUDY

Immune Therapeutics Expects to Generate New Revenue Stream and Contribute to Health Security in Nigeria

ORLANDO, FL – April 27, 2016 – Immune Therapeutics, Inc. (OTCQB: IMUN) (the “Company”), a clinical-stage biotech company providing immunotherapy solutions for the treatment of autoimmune disease and cancer with a focus on emerging nations, today announced that Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has approved its 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, and GB Pharma Holdings, to launch a nationwide marketing and sales program that is expected to generate new and significant revenue channels for the Company. The Company believes that this new sales revenue places it on-track towards achieving profitability and significant future revenue and earnings growth.

NAFDAC is the Nigerian agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, import/export, distribution, sale and use of food and drugs. Its approval for the Company to exclusively market and distribute Lodonal in Nigeria clears the way to complete the registration over the coming weeks

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.

Breakthrough Lodonal Results on HIV Patients:

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.

Due to its favorable cost/benefit, the Company believes Lodonal has large market potential to be the first affordable non-toxic therapy of its kind. It is administered in a single oral dose daily making medical and drug compliance much easier and is designed to produce a significant reduction in opportunistic infections. In addition to affordably improving the quality of patients’ lives, it offers a compelling economic benefit to health care systems.

Dr. Abayomi Oni, the Bridging Study’s local Principal Investigator and Medical Director at State Specialist Hospital Asubiaro, said, “The professionalism in this collaborative endeavor was outstanding and we are pleased to have been part of this international and medically significant accomplishment.”