TNI BioTech, Inc. Receives Confirmation of Transfer of IND application and Orphan Drug Designation
BETHESDA, Maryland-- (Marketwire –May 6, 2013) - TNI BioTech, Inc., (PINKSHEETS: TNIB) has received acknowledgement from the Department of Health and Human Services confirming the Food and Drug Administration’s (FDA) receipt of the change in sponsorship of the investigational new drug application (IND) for Naltrexone HCL and the orphan drug designation for [met5]-enkephalin and the orphan drug designation for the use of low dose naltrexone in the treatment of pediatric patients with Crohn’s Disease.
The Company signed an agreement for the acquisition of patent rights for the intellectual property of Dr. Jill Smith and LDN Research Group, LLC, whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the FDA to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s Disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses 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. For more information, please see the Material Information Disclosure filed with OTC Markets on January 8, 2013.
The Company signed an exclusive licensing agreement with The Penn State Research Foundation to license all of the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer titled “Opioid Growth Factor and Cancer” and “Combination Therapy with Opioid Growth Factor and Taxanes for the Treatment of Cancer.” As part of the Agreement, TNI BioTech acquired the orphan drug designation (IND), and clinical data set from Dr. Jill Smith. For more information, please see the Material Information Disclosure filed with OTC Markets on January 31, 2013.
The acknowledgements of the transfers of the IND and orphan drug designation referenced above are attached to the Material Disclosure filed with the OTC Markets on May 6, 2013.
About TNI BioTech, Inc.
TNI BioTech, Inc., is a biotech company working to combat chronic, life-threatening diseases through the activation modulating 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 program involves immunotherapy with met-enkephalin (MENK) and/or opioid growth factor (OGF), which has 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 low dose naltrexone and/or MENK 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.
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.
Please visit http://www.tnibiotech.com for more information.