ORLANDO, Fla. and HUBEI, China, Aug. 13, 2014 /PRNewswire/ -- TNI BioTech, Inc. (OTC: TNIB) (“TNI” or the “Company”) a biotechnology company pioneering the manufacturing and marketing of innovative therapies for autoimmune diseases in emerging nations, announced today the signing of a supplemental agreement with Hubei Qianjiang Pharmaceutical Co., Ltd (SHSE:600568) ( Qianjiang) China on behalf of Cytocom, TNI BioTech’s wholly owed subsidiary. The signing of the supplemental agreement accelerates clinical trial development in both America and China, for IRT-101 (“MENK”). In the hope of moving clinical development forward the parties agreed to the following:
- The parties agree to immediately initiate 3-mo GLP Toxicology Studies within 30 days of the signing of this agreement. GLP Toxicology Studies Trials will be run in China in accordance with international standards and acceptable to the FDA
- Qianjiang Pharmaceutical has raised the funds necessary for clinical development and marketing of MENK. Expenditures are subject to full budget approval by both Qianjiang and Cytocom and will be approved by Mr. Ye Jige, of Qianjiang Pharmaceutical, and, authorized by Noreen Griffin, CEO of TNI BioTech of the United States.
- Cytocom and Qianjiang Pharmaceutical will meet immediately with the SFDA to determine that PK and Dosing Trials completed in the US will be acceptable to the SFDA. All developments and trial results run by Cytocom in the United States or EU will be used for requesting registration approval in China
- Based on PK, Dosing and Existing Trial results in US, Qianjiang pharmaceutical and Dr. Graham Burton and Dr. Joseph Fortunak will meet with the SFDA to determine what additional data will be required to initiate corresponding trial in China.
The partnership will leverage the expertise and distinct assets and capabilities of each company in its respective field, namely Cytocom’s expertise in drug development, and Hubei’s financial, manufacturing and distribution capabilities.
Integrating these capabilities, the companies will utilize the collaboration’s joint assets to develop and commercialize products. The parties have agreed on revenue sharing from all MENK products developed through the collaboration.
Noreen Griffin and CEO of TNIB states, “This expansion of our agreement with Hubei today allows Cytocom to immediately move forward with our development plan for MENK. We expect our joint efforts will result in significant product and revenue opportunities for both Cytocom and Hubei.”
Chairman and President of Hubei Mr. Ye Jige, commented, “This collaboration with TNIB and Cytocom continues Hubei Qianjiang Pharmaceutical’s strategy to develop new products and to speed up the product commercialization process for our partners. This is the first step of the collaboration.”
About TNI BioTech, Inc.
TNI BioTech is 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.
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”) or Lodonal, 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 autoimmune states such as rheumatoid arthritis and multiple sclerosis; as an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery; and as a complement to antibiotics in the treatment of a variety of infectious diseases, including patients with HIV/AIDS, in combination with retroviral drug therapy.
About Hubei Qianjiang Pharmaceutical Co., Ltd
Hubei Qianjiang Pharmaceutical Co., Ltd., a Chinese public company (“SHSE: 600568") established in the 1970’s trading on the Shanghai Stock Exchange. The company owns high-tech production and manufacturing and distribution facilities, and a strong research and development department. The Company has passed the GMP certification and can produce 120 different products, including 15 kinds of preparations, such as eye drops, freeze dried injections, tablets, capsules, and cephalosporin powders for injections. The Company has two series of products, proprietary ophthalmic drugs and anti-infection drugs. The “jing” brand eye drops rank first in market share. The Company manufactures a brand of Acyclovir, clindamycin and other anti-virus products that have received national major new product certification. The ‘jing” and " gantai” trademarks have become famous brands in China that assure both quality and consumer satisfaction.
About Airmed Biopharma Limited
Airmed Biopharma Limited, a wholly owned Irish company, is the pharmaceutical sales division of TNI BioTech. Airmed is responsible for servicing sales orders for Lodonal in countries where TNI BioTech has received sales approval in Latin America and Africa.
About Cytocom, Inc.
Cytocom, Inc. is a biotechnology company that will initially focus on developing Low Dose Naltrexone (Lodonal) and met-enkephalin in the investigation of unmet medical needs in the areas of oncological and inflammatory diseases.
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.
For further information, please see http://www.tnibiotech.com
Contact: Dennis S. Dobson, 203-258-0159
SOURCE TNI BioTech, Inc.
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