TNI BioTech, Inc. announced 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.