Immune Therapeutics Announces Filing Acceptance Of New Drug Applications For Lodonal For The Treatment Of Patients With Human Immuno-Deficiency, Cancer And As An Immune Booster
WASHINGTON, Oct. 26, 2016 /PRNewswire/ -- Immune Therapeutics, Inc. (OTCQB: IMUN) (the "Company"), a clinical-stage biotech company providing immunotherapy solutions for the treatment of autoimmune disease and cancer, today announced that the Ministry of Health and Prevention Division of Pharmacy in the Republic of Senegal (the "Ministry of Health") accepted for review the Company's New Drug Applications ("NDAs") for LodonalTM as a stand alone or adjunct therapy non-toxic in the treatment of HIV/AIDS, cancer and as an immune booster.
The NDAs for LodonalTM are based on clinical data provided from Phase II trials in the United States, two Phase II trials for HIV in the Republic of Mali in West Africa, and the drug approval in the Republic of Nigeria as an immune system regulating agent in patients with Human Immuno-Deficiency Virus (HIV). LodonalTM met the primary and secondary endpoints for both efficacy and safety in its clinical trial in Nigeria.
While this data supports the acceptance of the NDAs by the Ministry of Health, this acceptance does not guarantee that LodonalTM will be approved by the Ministry of Health for the treatment of adults with HIV/AIDS, immuno-deficiency and/or cancer.
"LodonalTM demonstrates Immune Therapeutics' commitment to delivering affordable non-toxic innovative therapies for patients with chronic illness" said Professor Shan, the Company's Chief Science Officer and Head of Global Clinical Development. "If approved, LodonalTM would be the first affordable non-toxic therapy for the treatment of patients with HIV and cancer. We look forward to working with the Ministry of Health as we seek to gain approval of this innovative drug and further address the needs of patients with these debilitating conditions."
Ms. Griffin expressed that "We hope to continue with the filing of new drug applications throughout Africa in the coming months. This milestone could never have been reached without a clear regulatory process set forth by the Ministry of Health in Senegal and the support and dedication of Dr. Gloria Herndon of GB Pharma Holdings, Dr. Ndiouga Dieng and their team."
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 its patented immunotherapies with a focus of providing such therapies in emerging nations. Its 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 and autoimmune diseases.
The Company's proprietary technology, therapies and patents include the treatment of a wide range of cancers. Its most advanced clinical programs involve immunotherapy with met-enkephalin (MENK) (sometimes referred to as opioid growth factor) and its Low Dose Naltrexone product (LDN) or LodonalTM, which have been shown to stimulate the immune system even in patients with advanced cancer.
Forward Looking Statements
This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all of the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission, including its recent periodic reports.
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SOURCE Immune Therapeutics, Inc.
