NEW YORK and BETHESDA, Md., Jan. 8, 2013 /PRNewswire/ -- TNI BioTech, Inc. (PINKSHEETS: TNIB) announced today that it has signed an agreement for the acquisition of patent rights and orphan drug designation by the FDA to a novel late-stage drug, trademarked "LDN," for the treatment of Pediatric Crohn's Disease.
TNI BioTech has signed a licensing agreement to acquire the exclusive patent rights for the intellectual property of Dr. Jill Smith and LDN Research LLC, whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low dose as an opioid antagonist. Endogenous opioids and opioid antagonists have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues.
As part of the Agreement, TNI BioTech has the right to apply to the Food and Drug Administration (FDA) for the transfer of the orphan drug status, the investigational new drug applications (INDs), and the right to acquire the relevant clinical data set from Dr. Smith. The FDA has designated orphan drug status for the use of low dose naltrexone in the treatment of pediatric patients with Crohn's disease and ulcerative colitis.
The agreement calls for the formation of a Development Committee to monitor the clinical progress of the Licensed Products and will consist of independent scientific and technical leaders who are highly regarded by the scientific community in the Field of Use of each Licensed Product. The development committee will consist of at least one representative from the Licensor Parties and one representative from the Company in addition to outside experts in the field. The inventors input will be highly valued due to their history and expertise with the therapies.
"TNI BioTech is extremely pleased to acquire the exclusive rights to low dose naltrexone and other opioid antagonists for the treatment of inflammatory and ulcerative diseases of the bowel," stated Noreen Griffin, CEO of TNI BioTech. "We believe that low dose naltrexone has the potential to provide significant relief to those who suffer from Crohn's disease or other auto-immune disorders of the bowel." Low dose naltrexone has already been evaluated in two randomized placebo-controlled phase II trials, one for adult patients with Crohn's disease and the other for children with Crohn's disease by Dr. Jill Smith. Naltrexone in low dose has been well tolerated in almost all patients, and it showed significantly greater treatment efficacy than the control group in both trials. TNI BioTech is now planning to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment for patients with Crohn's disease using naltrexone in low dose. A platform immunomodulatory technology, naltrexone in low dose also is expected to be clinically tested for treatment of other immune-mediated or immune-deficient diseases, for which the company has previously acquired additional patents.
About TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech company working to combat chronic, life-threatening diseases through the activation and modulation 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, chronic inflammatory diseases and autoimmune diseases, such as HIV/AIDS.
Our proprietary technology, therapies and patents include the treatment of a wide range of cancers. Our most advanced clinical program involves immunotherapy with Methionine Enkephalin (MENK) also termed Opioid Growth Factor (OGF), which has been shown to stimulate the immune system even in patients with advanced cancer. Management considers any condition that results in altered-immune response as a target for investigation, and the Company will most likely pursue additional investigations for low dose naltrexone and/or MENK as valuable candidates in the treatment of the following:
- Autoimmune disorders such as rheumatoid arthritis and multiple sclerosis
- As an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery
- As an adjunct to antibiotics in the treatment of a variety of infectious diseases
- Patients with HIV/AIDS, in combination with retroviral drug therapy
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.
Contact: Global Investment Media
SOURCE TNI BioTech, Inc.