Earlier today, Immune Therapeutics, Inc. (OTCQB: IMUN) announced that Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has approved the company’s patented Lodonal™ as an over-the-counter, non-toxic adjunct therapy in the treatment of HIV/AIDS. With this approval, IMUN’s distribution partners, AHAR Pharma and GB Pharma Holdings, will now be able to launch nationwide marketing and sales programs for the breakthrough immunotherapy, creating a new revenue stream for IMUN and contributing to health security in Nigeria.
“Receiving approval of our affordable non-toxic immunodeficiency treatment Lodonal is a significant company milestone,” Noreen Griffin, chief executive officer of IMUN, stated in this morning’s news release. “Supported by a new and growing body of clinical research, we expect Lodonal will be increasingly proven as an effective treatment for patients suffering from a comprised immune system and other autoimmune conditions as it prepares for commercialization.”
The NAFDAC approval comes as a result of the successful completion of a 90-day bridging study conducted by AHAR Pharma at the State Specialist Hospital in Nigeria. The results of the Nigerian study were consistent with IMUN’s previous clinical trials of Lodonal, yielding an average increase of 44 percent in CD4 count in the treatment group, as compared to an increase of just 11 percent in the control group. Higher CD4 counts have been linked to increased ability to fight HIV and other infections. According to the U.S. Department of Health & Human Services (http://dtn.fm/QU4dS), CD4 count is the ‘most important laboratory indicator of how well [the] immune system is working and the strongest predictor of HIV progression’.
The market potential of Lodonal in Nigeria, which is Africa’s leading economy with more than 175 million people, is immense. Among its many benefits, Lodonal is cost-effective and easy to administer, requiring just a single daily oral dose. In addition to affordably improving the quality of life of patients, the therapy also offers a compelling economic benefit to national health care systems, as it is designed to produce a significant reduction in opportunistic infections.
The path of destruction created by the HIV/AIDS epidemic in sub-Saharan Africa is staggering. According to AVERT (http://dtn.fm/hPF5o), a global provider of HIV/AIDS education, roughly 24.7 million people in the sub-Saharan region were living with HIV in 2013. Among those individuals, just 39 percent of adults were on antiretroviral treatments. When combined with the knowledge that an estimated 75 percent of adults in the region with HIV who are currently accessing antiretroviral treatments have not yet achieved viral suppression, the critical need for IMUN’s innovative adjunct therapy is clearly demonstrated.
“While we finalize the registration process… we will focus on distribution throughout Nigeria,” continued Griffin. “Simultaneously we will be working to leverage the successful clinical trial results and NAFDAC approval to expedite the approval and distribution into the many other African nations that have been devastated by HIV/AIDS for the past 17 years.”
Learn more by visiting www.immunetherapeutics.com
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