IMUN news: Immune Therapeutics, Inc. Files Lodonal New Drug Application in Kenya
Apr 25, 2017
OTC Disclosure & News Service
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ORLANDO, Fla., April 25, 2017 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTCQB:IMUN), a clinical-stage biopharmaceutical company developing therapies for a range of conditions using LodonalTM its proprietary formulation of lower-dose naltrexone, today announced it has submitted its New Drug Application (NDA) to the Pharmacy and Poison Board (PPB) in Kenya for Lodonal for the treatment of patients with HIV and cancer, both as a standalone treatment as well as an adjunct treatment, and as an immunomodulator.
“This NDA submission initiates the process we believe will result in broad access to this our therapy for those suffering from immune deficiency disease and cancer,” said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. “We recognize the difficulty the immune-comprised community has had in obtaining affordable non-toxic therapies and look forward to working closely with the PPB as they review our application.”
A full preclinical and clinical study program supports the filing including: four clinical efficacy trials involving more than 500 HIV/AIDS patients, and one clinical trial with 89 patients for cancer and over 1,200 patients with autoimmune disease. The clinical data showed that Lodonal could improve CD4 count, decrease viral load and reduce the number of opportunistic infections in patients suffering from comprised immune systems.
Omaera Pharmaceuticals, Ltd and GB Pharma Holding supported this filing. “Without their support, the fast track of this process would not have been possible,” noted Griffin. The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. “The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement,” concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.
“We look forward to a smooth regulatory process for Lodonal in Kenya. We have significant experience with Kenya’s PPB and have meetings planned with the Ministry of Health before the end of the month,” notes Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings of Washington, DC
