19 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: TNI BioTech and Hubei Qianjiang Pharmaceutical, a leading Chinese pharmaceutical company will co-develop new cancer drugs based on TNI BioTech's patents involving Methionine Enkephalin, which when approved will be marketed in China under the band name IRT-101 and IRT-102.
Under the Supervision of Dr Ronald Herberman, CMO, and Professor Fengping Shan,CSO, TNI BioTech, will maintain oversight responsibility for pre-clinical and clinical trials in China complying with both FDA and SFDA standards. The companies believe this joint development will fast track the drugs for the Chinese pharmaceutical markets.
Hubei Qianjiang Pharmaceutical, has committed a minimum of 10 million yuan, approximately $1,600,000 dollars, for pre-clinical work. The pre-clinical trials, designed to assess safety, tolerability and antitumor activity of Methionine Enkephalin, are required in China as Methionine Enkephalin is a new drug.
Once the companies complete pre-clinical studies, TNI BioTech will apply for clinical trials with SFDA. Hubei Qianjiang Pharmaceutical will provide the funding for clinical trials in China to have Methionine Enkephalin approved as a new drug for the treatment of cancer. Methionine Enkephalin potential in fighting cancer was identified in completed phase I and early phase II trials in the United States. During phase I and phase II trials, Methionine Enkephalin exhibited encouraging anti-tumor efficacy and a favorable toxicity profile.