ORLANDO, Fla. and DUBLIN, May 4, 2015 /PRNewswire/ -- 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.
About the Company
The Company is a biotechnology company working to combat chronic, life-threatening diseases through the activation and modulation of the body’s immune system using our patented immunotherapy. Our products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.
Our proprietary technology, therapies and patents include the treatment of a wide range of cancers. Our most advanced clinical programs involve immunotherapy with met-enkephalin (“MENK”) (sometimes referred to as opioid growth factor) and our Low Dose Naltrexone product (“LDN”) or Lodonal, which have been shown to stimulate the immune system even in patients with advanced cancer.
Even though Management considers any condition that results in altered-immune response a target for investigation, the Company will most likely pursue additional investigations for MENK and LDN as valuable candidates in the treatment of autoimmune states such as rheumatoid arthritis and multiple sclerosis; 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.
About Airmed Biopharma Limited
Airmed Biopharma Limited, a wholly owned Irish company, is the pharmaceutical sales division of the Company. Airmed Biopharma Limited is responsible for servicing sales orders for Lodonal where the Company has received sales approval in Latin America and Africa.
About Cytocom Inc.
Cytocom Inc. is a biotechnology company that will initially focus on developing LDN (Lodonal) and MENK in the investigation of unmet medical needs in the areas of oncological and inflammatory diseases.
About GB Pharma Holdings
GB Pharma Holdings is a Washington D.C. global Pharmaceutical company with expertise in defining policies, facilitating approvals, distribution and cGMP (Good Manufacturing Practices) and introducing innovative therapies to Africa. GB Pharma Holdings was established in order to be on the forefront of change and “providing innovative and sustainable solutions” GB Pharma Holdings is dedicated to bringing cost effective and quality products to Africa. We are able to link new technologies, science and education together to be a cause for good. GB Pharma Holdings core focus is twofold; manufacturing cGMP quality pharmaceuticals and helping existing government agencies develop testing and regulations to purge counterfeit and sub-potent products out of their respective countries.GB Pharma Holdings sources products directly from manufacturers able to provide quality pharmaceuticals and medical products. We are able to provide pedigree of any products we provide. Quality of products we distribute is guaranteed through testing reports, closed loop network and meticulous tracking from acquisition to final delivery on every product we provide. Our relationship with several universities in the United States and teaching Hospitals keeps us on the cutting edge of proven new trends & technologies. Additionally, we have an excellent relationship with international agencies and regulatory bodies. This link helps us develop cost effective therapies and products.
About America Hospitals and AHAR Pharma
Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 28 years of experience, is the founder of AHAR Pharma. Dr. Afonja is the CEO of Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton Health Care, which is an HMO that has been operating in Nigeria since 2000. He is also the founder of American Hospitals and Resorts Limited, a cancer and blood disorder treatment center (americanhospitals.org) that has been delivering high quality healthcare in Nigeria since 2007.
AHAR Pharma is a pharmaceutical company, which operates in the West and East Africa markets. AHAR specializes in branded medicines and seeks to improve the lives of patients suffering from infectious diseases.
Cautionary Note Regarding Forward-Looking Statements
This document includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about the plans, objectives, expectations and intentions of the Company, including the benefits of the spin-off of Cytocom Inc. from the Company, and other statements that are not historical facts. These statements are based on the current expectations and beliefs of our management and are subject to uncertainty and changes in circumstances. We caution readers that any forward-looking information is not a guarantee of future performance and that actual results may vary materially from those expressed or implied by the statements herein due to the conditions to the consummation of the spin-off of Cytocom Inc. from the Company, and changes in economic, business, competitive, technological, strategic and/or regulatory factors, as well as other factors affecting the operation of the other businesses of the Company and Cytocom Inc. More detailed information about these factors may be found in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K in the sections entitled “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors.” Various other factors could cause actual results to differ from those set forth in the forward-looking statements, including, without limitation, the risk that the anticipated benefits from the spin-off may not be fully realized or may take longer to realize than expected. We are under no obligation to, and expressly disclaim any such obligation to, update or alter our forward-looking statements, whether as a result of new information, future events, or otherwise. The Company undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof. For further information, please http://www.immunetherapeutics.com
Contact: Dennis S. Dobson, 203-258-0159
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SOURCE Immune Therapeutics Inc.
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