NEW YORK, NY -- (Marketwire) -- 10/18/12 -- TNI BioTech, Inc. (PINKSHEETS: TNIB) and Hubei Qianjiang Pharmaceutical Co., Ltd., a leading Chinese pharmaceutical company, today announced an agreement to co-develop new cancer drugs based on TNI BioTech's patents involving Methionine Enkephalin which when approved will be marketed in China under the brand name IRT-101 and IRT-102.
Under the Supervision of Dr. Ronald Herberman, Chief Medical Officer, and Professor Fengping Shan, Chief Science Officer, TNI BioTech, Inc. will maintain oversight responsibility for pre-clinical and clinical trials in China complying with both FDA and SFDA standards. The companies believe this joint development will fast track the drugs for the Chinese pharmaceutical markets.
Hubei Qianjiang Pharmaceutical Co., Ltd. has committed a minimum of 10 million yuan, approximately $1,600,000 dollars, for pre-clinical work. The pre-clinical trials, designed to assess safety, tolerability and antitumor activity of Methionine Enkephalin, are required in China as Methionine Enkephalin is a new drug.
Once the companies complete pre-clinical studies, TNI BioTech, Inc. will apply for clinical trials with SFDA. Hubei Qianjiang Pharmaceutical Co., Ltd.will provide the funding for clinical trials in China to have Methionine Enkephalin approved as a new drug for the treatment of cancer. Methionine Enkephalin's potential in fighting cancer was identified in completed Phase I and early phase II trials in the United States. During Phase I and Phase II trials, Methionine Enkephalin exhibited encouraging antitumor efficacy and a favorable toxicity profile.
"This alliance with TNI BioTech validates Hubei Qianjiang Pharmaceutical Co., Ltd.'s business model of co-developing novel compounds as therapies for Chinese markets in conjunction with a U.S. biotech company," said Mr. Ye Jige, President of Hubei Qianjiang Pharmaceutical Co., Ltd. "The initiation of the pre-clinical trials for IRT-101 and IRT-102 in China is a significant achievement for the development of Hubei Qianjiang Pharmaceutical Co., Ltd. and it represents both an important development milestone for this promising cancer drug and illustrates the benefits of Chinese and Western biopharmaceutical companies working together to efficiently carry out drug development. This important step will expedite the clinical development process of IRT-101 and IRT-102 in China."
Noreen Griffin, CEO of TNI BioTech, at the signing ceremony in Qianjiang China said,"This agreement illustrates TNI BioTech's ability to draw upon its patents to build alliances that help biopharmaceutical companies navigate the approval process of new therapies and further illustrates our strategy to maximize the potential of biopharmaceutical development and innovation for the benefit of patients and our shareholders."
About Hubei Qianjiang Pharmaceutical Co., Ltd
Hubei Qianjiang Pharmaceutical Co., Ltd. is a Chinese public company established in the 1970s 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 TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech company combating fatal diseases through the activation and mobilization 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, will be used to treat a wide range of cancers. Our most advanced clinical programs involve immunotherapy that works by isolating a patient's lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. After incubation the patient's lymphocytes are re-infused back into the patient where they combat and destroy tumor cells.
However, 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 as a valuable candidate in the treatment of the following:
•Autoimmune states such as rheumatoid arthritis and multiple sclerosis; •As an adjunct to antibiotics in the treatment of infectious diseases; •In cancer patients undergoing chemotherapy, radiation treatments or surgery; •Patients with AIDS, in combination with retroviral drug therapy; and •In wound healing or herpes viral infections.
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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