TNI BioTech, a biotech company working on chronic, life-threatening diseases, has formed a new subsidiary, Cytocom, for developing Low Dose Naltrexone (LDN) and Met-enkephalin (MENK).

TNI BioTech has spent the last year developing a manufacturing and distribution network for sale of LDN into emerging nations and has had discussions with the FDA and EMA to begin clinical trials in the U.S.

The company has considered whether to separate the development activities of the company, and the manufacturing and distribution of its novel therapies into emerging nations. Due to the differences in experience required to run a development business and a distribution business, the company believes now is the right time to separate these business lines before beginning its clinical trials and platform development of the biopharmaceuticals business. While both businesses have moved forward this year under single management, they have distinctly different business models, sales channels, customers, capital requirements and the need for very different management.

TNI BioTech has entered into consulting arrangements with Graham Burton, M.D., Ph.D., and Gary G. Gemignani, two biotech/pharma executives, to focus on the clinical advancement of LDN and MENK. It is anticipated Burton and Gemignani will enter into employment agreements with Cytocom to become CEO and chief operating officer/chief financial officer, respectively.

Burton will be responsible for leading Cytocom's global development, clinical research and medical initiatives. Gemignani will be responsible for operational and business development activities and financial management of Cytocom.