ORLANDO, Fla., March 26, 2014 /PRNewswire/ -- TNI BioTech, Inc. (OTC: TNIB), today announced that it has signed a 'Supplementary Cooperation Agreement (the "Agreement") on New Drug Methionine-Enkephalin' with Hubei Qianjiang Pharmaceutical Co., Ltd. (a Chinese listed company, hereinafter referred to as "Qianjiang").
Following TNI BioTech's FDA meeting in August of 2013, in which the FDA approved TNI BioTech to study Methionine-Enkephalin ("MENK") in clinical trials for pancreatic cancer advancing TNI BioTech's path to End of Phase II and the possibility of Phase III studies, Qianjiang has engaged in significant market research and pre-trials on pharmaceutical and pharma-toxicology studies, which suggest initial positive results.
In order to accelerate clinical trials in America and China, Qianjiang and TNI BioTech have agreed that Qianjiang will immediately start clinical trials in China. According to the previous agreements and as expanded by this latest Agreement, Qianjiang will provide funding for such studies and TNI BioTech will provide all its research materials, data, and results in America to Qianjiang and Qianjiang and TNI BioTech will seek registration for MENK in China. If and when manufacturing approval is achieved from the Chinese Government, Qianjiang will produce and sell MENK in China subject to the terms of a further agreement with TNI BioTech.
IRT-101 (MENK) is an active immunotherapy with MENK for patients with deficient functioning of the immune system. It works by restoring the patient's immune functions and by activating the lymphocytes to attack cancer cells and infectious diseases, such as HIV/AIDS. This is accomplished because MENK binds to opioid receptors on both immune cells and on cancer cells, which directly inhibits the growth of cancer cells and increases the number and functions of T-cells, NK cells, NK-T cells, and gamma/delta T-cells. These cells then destroy infective organisms and tumor cells while simultaneously inhibiting the ability of T regulatory (Treg) cells to block the functions of anti-cancer or anti-infectious disease lymphocytes.
About TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech 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.
Our proprietary technology, therapies and patents include the treatment of a wide range of cancers. Our most advanced clinical programs involve immunotherapy with met-enkephalin ("MENK") (sometimes referred to as opioid growth factor ("OGF") and our Low Dose Naltrexone product ("LDN"), which have been shown to stimulate the immune system even in patients with advanced cancer. Even though management considers any condition that results in altered-immune response a target for investigation, the Company will most likely pursue additional investigations for MENK and LDN as valuable candidates in the treatment of the following: autoimmune states such as rheumatoid arthritis and multiple sclerosis; as an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery; and as an adjunct to antibiotics in the treatment of a variety of infectious diseases, including patients with AIDS, in combination with retroviral drug therapy.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release and the statements of representatives and partners of TNI Biotech, Inc. and its subsidiaries (the "Company") related thereto include 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 "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" used in the Company's press releases and in the Company's filings with the Securities and Exchange Commission as well as 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 assumptions and significant risks and uncertainties. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release, and thus readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. Actual results may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof.
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Dennis S. Dobson
SOURCE TNI BioTech, Inc.