BETHESDA, Md - (Eteligis via Accesswire ) -- TNI BioTech, Inc. ("TNIB", the "Company") (OTCQB: TNIB) announced today that it has a Type C Meeting with the FDA in Washington, D.C., to review the Company's Development Program for its Phase III Drug Candidate, Naltrexone HCL [Low Dose Naltrexone (LDN) IRT-103
The Company attended a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the review of the development plan for its Phase III drug candidate, Naltrexone HCL [Low Dose Naltrexone] (LDN) IRT-103 , for the treatment of the inflammatory and ulcerative diseases of the bowel, in particular Crohn's Disease, using naltrexone in low dose as an opioid antagonist. Endogenous opioids and opioid antagonists at low doses have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues.
"The Type C meeting with the FDA allowed us to review our drug development programs before we begin enrolling our Phase III clinical trial," said Dr. Angus Dalgleish Chief Medical Officer. Noreen Griffin, TNI BioTech CEO stated, "We truly appreciate the FDA granting the meeting and for assisting us in better understanding the regulatory pathway as we move forward with our Phase III clinical trials. "We are very grateful to TNIB employees and regulatory advisors that participated in the meeting with the FDA: Augus Dalgleish, MD, Chief Medical Officer, TNI BioTech, Warren Strober, M.D. Chief, Mucosal Immunity Section, National Institute of Health, IBD Expert; Nita U. Patel, Ph.D., Vice President, The Weinberg Group Inc., Regulatory Consultant; Annie Foster, B.S, VP for Clinical and Regulatory Affairs, Dr. Jeffrey Hyams, Director, Gastroenterology Department, Connecticut Children's Medical Center and Joseph Fortunak, PhD, Assoc. Prof. of Chemistry and Pharmaceutical Sciences, Howard University School of Pharmacy; CMC Consultant to TNI BioTech and for all of their great work on behalf of TNI BioTech."
About TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech company with the goal of benefitting patients with chronic and often life-threatening diseases through the activation and rebalancing of the body's immune system, using a patented immunotherapy.
Their products, technologies, and patents are designed to harness the power of the immune system to improve the treatment of cancer, chronic infections such as HIV/AIDS, and autoimmune diseases and, such as Crohn's disease, other types of inflammatory bowel disease, and multiple sclerosis.
TNI BioTech's most advanced clinical programs involve immunotherapy with methionine-enkephalin (MENK) or low dose naltrexone (LDN), which both work by triggering opioid receptors on immune cells, leading to an activation and expansion of various cells of the immune system.
Their proprietary technology, therapies, and patents are planned to treat a wide range of cancers. Their most advanced clinical programs involve immunotherapy that works by augmenting the number and functions of both T cells and natural killer (NK) cells in patients with deficient immune responses associated with advanced cancer or HIV/AIDS and by rebalancing the immune responses in patients with autoimmune diseases, including Crohn's disease and multiple sclerosis (MS).
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release includes 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 the Company's expectations or beliefs concerning future events. Statements containing expressions such as "believes," "anticipates," "intends," or "expects," used in the Company's press releases and in 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 risks and uncertainties. Although the Company believes its expectations are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there can be no assurances that actual results will not differ materially from expected results. The Company cautions that these and similar statements included in this report are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. The Company undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof.
See http://www.tnibiotech.com for more information.
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SOURCE: TNI Bio Tech, Inc.
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