As part of the agreement between TNI BioTech, Inc. and the University of Pennsylvania, Dr. Jill Smith , Dr. Ian S. Zagon , Dr. Patricia J. McLaughlin , and Moshe Rogosnitzky , the company gained the right to apply to the Food and Drug Administration (FDA) for the transfer of the Orphan Drug Designation and the Investigative New Drugs (IND) status. The company is pleased to announce that on April 3, 2013, it received acknowledgement from the Department of Health and Human Services confirming the FDA's receipt of the change in sponsorship of the IND application for Naltrexone HCL along with the orphan drug designation for both [met5]-enkephalin and low dose naltrexone (LDN) in the treatment of pediatric patients with Crohn's disease.
In May 2013, TNI BioTech, Inc. received confirmation of a Type C meeting with the FDA to discuss the Phase III clinical development program for a proposed 505(b)(2) application for low dose naltrexone (LDN) in the treatment of adults and pediatric patients with Crohn's disease. Additionally, the agreement with their partners was expanded to include clinical trials on pancreatic and liver cancer, allowing the company to fast track the development plans for pancreatic and liver cancers. The company is also moving forward in developing its other therapies and hopes to set additional FDA meetings to discuss the clinical trials for pancreatic cancer and other autoimmune diseases.
In March 2013, TNI BioTech, Inc. made a strategic decision to outsource its manufacturing. This decision was made when the joint venture partner was unable to provide a facility that met international standards for manufacturing resulting in the cancelling of the contract. The company concurrently entered into discussions with an existing facility in Managua, Nicaragua
SOURCE TNI BioTech, Inc.
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