ORLANDO, Fla. and DUBLIN, Oct. 30, 2014 /PRNewswire/ -- TNI BioTech, Inc., (OTC-TNIB) (“TNIB”) or the (“Company”), headquartered in Orlando, Florida and Dublin, Ireland, a specialty pharmaceutical company involved in the manufacture, distribution and marketing of novel, patented therapies to combat chronic, life-threatening diseases through the activation and modulation of the body’s immune system, through its wholly owned subsidiary TNI BioTech International Ltd., today announces the initiation of a 90-day bridging trial in Nigeria of Lodonal in patients with HIV/AIDS.
The approval of a 90-day bridging trial by the National Agency for Food and Drug Administration and Control (“NAFDAC”) is an important milestone in TNIB’s business strategy. The bridging trial goal is to supplement clinical data submitted to NAFDAC to confirm safety, tolerability and efficacy in the local population. Upon successful completion of this trial in February 2015, TNIB will begin marketing Lodonal in Nigeria.
The trial has been approved and will be overseen by NAFDAC and will be conducted at the State Hospital Asubiaro, in Osogbo, Osun State, Nigeria under the supervision of Dr. Abayomi Oni, Chief Consultant, and Dr. Richards Afonja, Principal Investigator.
TNIB is focused on the application and commercialization of Lodonal as a novel immune modulator that can be orally administered once a day. After conclusion of this trial, TNIB, in conjunction with Dr. Afonja, will file protocols to begin trials for Lodonal as an immune modulator and as an adjunct treatment in chemotherapy and other opportunistic infections. Successful Phase I and Phase II clinical trials have been completed for HIV/AIDS, cancer and immune therapy.
Noreen Griffin, CEO of TNIB, said, “We are delighted that the development of our lead product Lodonal has progressed to this stage within such a short timeframe. We are on track to rapidly move this innovative therapy through the final approval process, so that it can become available to all HIV/AIDS patients in desperate need for a non-toxic treatment option. Upon successful completion of this trial, we are prepared to make Lodonal available to the largest population in Africa.”
Dr. Richards Afonja, President of AHAR Pharma, said, “The objectives of this bridging randomized, placebo-controlled study is to assure safety and tolerability as well as efficacy with the local population. We intend to recruit up to 150 HIV/AIDS patients for this study. We are very fortunate that the trial is being run at the preeminent HIV/AIDS hospital in Nigeria led by one of the leading doctors in the country.”
Dr. Gloria B. Herndon, a Director of TNIB, said “We wish to thank everyone who was involved in making this trial possible. Now it is time for Africa, with its emerging healthcare strategies, to enhance the health of its citizens. Commencement of this trial serves as a wake-up call that a healthy body and strong immune system are combatants to diseases and opportunistic infections. Africa recognizes that securing the health of its citizens is paramount to strong economic development and growth.”
About TNI BioTech, Inc. and Cytocom, Inc.
Further information about TNI BioTech and Cytocom may be found in our SEC filings and previous public announcements.
About AHAR Pharma
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.
Dr. Richards Afonja, a Hematologist/Oncologist, living and working in New Jersey and Nigeria with over 26 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 (http://americanhospitalsandresorts.com) that has been delivering high quality healthcare in Nigeria since 2007.
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 proposed 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 proposed 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 proposed 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.
Contact:
Dennis Dobson, Dobson Media Group, 203-258-0159
SOURCE TNI BioTech, Inc.
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