Data for review in connection with the New Drug Application to NAFDAC for use as an immune booster and adjunct treatment for Human Immunodeficiency Virus
ORLANDO, FL AND DUBLIN, IRELAND / ACCESSWIRE / January 21, 2016 / Immune Therapeutics Inc., a U.S. public company (OTCQB: IMUN) today announced that it has completed its 90-day bridging trail of Human Immunodeficiency Virus positive [HIV+] patients and submitted data to The National Agency for Food and Drug Administration and Control, (NAFDAC) in connection with the approval of LodonalTM as an immune booster that can improve the health of those effected by human immunodeficiency virus [HIV+] and people with a comprised immune systems. The primary objectives of the clinical trial was to confirm that LodonalTM is first and foremost safe for use in the local population and secondly has a beneficial effect on the immune system of patients with a compromised immune system such as HIV+ individuals. Immune enhancement and/or balance will be determined by the number of subjects receiving LodonalTM with CD4 count stabilization (less than 10% change from baseline mean values) or 25% increase in CD4 counts on LodonalTM compared to placebo group from baseline.
We are very excited having achieved this major milestone in collaboration with our partner organizations AHAR Pharma and GB Pharma Holdings. The submission for LodonalTM was made possible in a short time frame due to the professionalism and thoroughness we received from NAFDAC, said Dr. Nicholas Plotnikoff, non-executive chairman "We look forward to continuing to work with NAFDAC as they review approval for LodonalTM as a general immune booster and adjunct treatment for HIV+ patients."
"These past months have been enormously active and productive for IMUN and our partner, AHAR Pharma. In September we completed enrollment of our bridging trial and today IMUN is able to announce completion of the trial and the submission of data in connection with the filing of its New Drug Application for LodonalTM with NAFDAC, said Noreen Griffin CEO of IMUN. "Thus far, 150 patients have been treated in our study with Lodonal and we are making excellent progress in the development and preparation for commercialization of this investigational drug once we obtain approval. It is the goal of IMUN, GB Pharma Holdings and AHAR Pharma to advance science and drug development in the hopes of making a significant difference for the betterment of patients with serious unmet healthcare needs, "With the announcement today we have accomplished an important milestone in our timeless journey, which would not have been possible without the support of our partners Dr. Gloria B. Herndon, Dr. Richards Afonja the team in Africa the Principal Investigator Dr. Abayomi Oni and the patients "
As part of the process the Company signed a Letter of Intent for exclusive distribution rights in Nigeria with Fidson's Healthcare PLC, on August 3, 2015 and has reached agreements on the terms and conditions of the contract and expect to sign the agreement upon approval of for LodonalTM by NAFDAC.
About Immune Therapeutics, Inc.,:
Immune Therapeutics, Inc., (formally known as TNI BioTech, Inc),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(TM), 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, we 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 TNI BioTech International, Ltd.:
TNI BioTech International, Ltd., a wholly-owned subsidiary of Immune Therapeutics, Inc. incorporated in the British Virgin Islands, is responsible for managing Immune Therapeutics' international distribution and is the contracting entity for the Nigerian 90-Day Lodonal(TM) Bridging trial.
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 (current Good Manufacturing Practices) and introducing innovative therapies to Africa. GB Pharma Holdings was established in order to be on the forefront of change and 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.
Additionally, 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 and technologies. Additionally, we have an excellent relationship with international agencies and regulatory bodies.
About American Hospitals and Resort:
Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 28 years of experience, is the founder of American Hospitals & Resort [AHAR], a cancer and blood disorder treatment center (americanhospitals.org) that has been delivering high quality healthcare in Nigeria since 2007. AHAR Pharma is the associated 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. Associated organizations include Paterson Medical Services Corp, Colfax Oncology, Inc. and Princeton Health Care, which is an HMO that has been operating in Nigeria since 2000, both entities were founded and are managed by Dr. Richards Afonja.
About Fidson Healthcare:
Fidson Healthcare Plc., is a leading pharmaceutical company in Nigeria and the West African sub-region. The Company is listed on the Nigerian Stock Exchange and has over 200 products across several therapeutic classes. Her product portfolio cuts across anti-infective, gastrointestinal, antiretroviral, anti-malarial, cardiovascular, analgesic, haematinics and supplements. The Company started operations in 1995 and set up its first local manufacturing facility in July 2002. The company was awarded the NIS: ISO 9001:2008 certification in 2011 by the International Standard Organization (ISO) in recognition of her world-class management systems. To achieve her strategic imperative of consistently improving its products and consolidate its market position, Fidson has continued to invest in research and development across various disease areas. The company has recorded a number of firsts, key among which was becoming the first company in Sub-Saharan Africa to manufacture antiretroviral drugs in 2005.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release and the statements of our management, representatives and partners and our subsidiaries related thereto include various "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which represent our expectations or beliefs concerning future events. Statements containing expressions such as "plan," "project," "potential," "seek," "may," “will,” "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" used in this press releases and in our filings with the Securities and Exchange Commission as well as Disclosure Statements and Reports filed with the Over The Counter Markets through the OTC Disclosure and News Service are intended to identify forward-looking statements. All forward-looking statements involve assumptions and significant risks and uncertainties. Readers are cautioned that certain important factors may affect our actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release, and thus readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. Actual results may differ significantly from those set forth in the forward-looking statements. We undertake no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof.
For more information please contact:
Mike King
Director, Princeton Research, Inc.
3887 Pacific St
Las Vegas, NV 89121
Office: (702) 650-3000
Web: www.princetonresearch.com
FB: www.facebook.com/princetonresearch
SOURCE: Immune Therapeutics Inc.
