20 Jan 90-Day Bridging Trial in Nigeria
Posted at 22:19h in GB NEWS
GB Pharma Holdings in collaboration with its partner AHAR Pharma, initiate 90-Day bridging trial for the efficacy of Low Dose Naltrexone [LDN], marketed as Lodonal™, in HIV/AIDS patients.
The Commissioner of Health and Permanent Secretary gave final patient approval from the Ministry of Health from Osun State Government for the 90-day trial. In coordination with the Nigerian National Agency for Food and Drug Administration and Control (“NAFDAC”), the Osun State Research and Ethics Committee (“OSHREC”) will oversee all aspects of the 90-day trial. It is expected that quantitative data that includes CBC with differentials, CMP, CD4 and alpha-interferon and qualitative data that is based on the Company’s developed questionnaire, will be collected on Day 1, Day 45 and Day 90 of the trial.
The trial is being sponsored by Immune Therapeutics, a publicly listed company and managed through its fully owned subsidiary TNI Biotech International Ltd.
Dr. Gloria B. Herndon, a consultant for Immune Therapeutics and former director said, “Nigeria, as the leader in Africa, made this monumental step toward enhancing a health advantage for its country and the continent of Africa. Just as Nigeria took the leadership in Africa against Ebola, it is once again taking up the charge of supporting innovative immune therapy. At the brink of this 90-day trial, it is with great anticipation that some of our supporters such as US Doctors for Africa (‘USDFA’) and founder Ted M. Alemayhu, look forward to the results of this NAFDAC approval process so that more people affected by AIDS/HIV can be given another chance for higher quality life. Results of this 90-day trial will further support the resolution on Lodonal™ during the first ever Pan-African Health Summit, led by USDFA, in May 2014.”
Dr. Richards Afonja, President & CEO of AHAR Pharma, who serves as Principal Investigator for the 90-day trial, has secured all funding and resources for the duration of the study. Chief Consultant on this trial, Dr. Abayomi Oni, will oversee all quantitative and qualitative data collection. Dr. Oni reports to the Directors of the OSHREC and subsequently NAFDAC.
Dr. Afonja said, “With the AIDS epidemic in Africa and other types of immune compromised states, affordable, available and effective treatment with Lodonal™ resulting in increased CD4 count, reducing opportunistic infections and the high mortality rate associated with these infections, the continent of Africa stands to gain tremendously as the population decimation by these infections is dangerous.
In honor of her husband’s memory Ms. Jackie Bihari stated earlier this week, ” I cannot convey to all of you how thrilled and delighted I am that a clinical trial using Lodonal™ in combating the HIV virus is being initiated in Nigeria. It was always Dr. Bihari’s dream that one day these trials would begin and would lead to the logical conclusion that everyone would have access to this affordable drug. Thanks to all of your unending hard work and belief in Lodonal™, his wish has become a reality. Hopefully one day Lodonal™ will become available to everyone in developing countries; especially to the millions of people in Africa who have long been suffering with the HIV virus. I thank you from the bottom of my heart — you are absolutely the best and I am honored to be part of your team. I am sending you my blessings and love and know that with all of your positive passion for Lodonal™, the trial will be a success. The saddest part of this day is that Dr. Bihari never had the privilege and honor to meet all of you … you are all as the song title goes ‘Simply the Best.'”
Dr. Bernard Bihari’s research on 4.5mg Naltrexone, referred to as “Low Dose Naltrexone” and trademarked Lodonal™, began over 25 years ago on patients suffering from HIV/AIDS, various cancers, Multiple Sclerosis and numerous neurodegenerative diseases.
ABOUT GB PHARMA HOLDINGS: is focused on providing quality and innovative therapies in field of pharmacology throughout Africa. Whether through the provision of quality brand name and generic pharmaceuticals, expertise in developing quality control policies and structures, training in pharmacology or best practices in the implementation of current Good Manufacturing Practices [cGMP] in pharmaceutical manufacturing.
ABOUT AHAR PHARMA: was formed by Dr. Richards Afonja, a Hematologist / Oncologists living and working in New Jersey and Nigeria with over 26 years of experience. Dr. Afonja is the Founder and CEO of a number of Medical companies including Paterson Medical Services Corp, Colfax Oncology, Inc with three offices in New Jersey for the treatment of cancer and blood disorders, Princeton Health Care an HMO, located in Nigeria since 2000; and American Hospitals and Resorts Limited (AHAR) a cancer and blood disorder treatment center (http://americanhospitalsandresorts.com) that has been delivering high quality healthcare since 2007 in Lagos, Nigeria.
AHAR Pharma is a Pharmaceutical company which operates in the markets of both West and East Africa. Our parent company America Hospitals and Resorts for more than 2 years have been trusted by patients, healthcare professionals and business partners. AHAR specializes in branded medicines. Improving the lives of patients, whether it is by fighting infections, controlling cholesterol, relieving the symptoms of asthma, or providing lifesaving medicines and pain relief for cancer sufferers and general individuals from hospitals to pharmacies, to clinics.
ABOUT IMMUNE THERAPEUTICS: We are 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.