TNI BioTech and Hubei Qianjiang link up on cancer drug development

US biotech firm TNI BioTech (OTC: TNIB) has signed a supplemental agreement with China’s Hubei Qianjiang Pharmaceutical (SHSE: 600568) on behalf of Cytocom, TNI BioTech's wholly owned subsidiary.

The signing of the supplemental agreement accelerates clinical trial development in both America and China, for IRT-101 (MENK). In the hope of moving clinical development forward the parties agreed to the following:

1. The parties agree to immediately initiate 3-mo GLP toxicology studies within 30 days of the signing of this agreement. GLP toxicology studies trials will be run in China in accordance with international standards and acceptable to the Food and Drug Administration.
2. Qianjiang Pharmaceutical has raised the funds necessary for clinical development and marketing of MENK. Expenditures are subject to full budget approval by both Qianjiang and Cytocom and will be approved by Ye Jige of Qianjiang Pharmaceutical, and authorized by Noreen Griffin, chief executive of TNI BioTech.
3. Cytocom and Qianjiang Pharmaceutical will meet immediately with the SFDA to determine that PK and dosing trials completed in the USA will be acceptable to the SFDA. All developments and trial results run by Cytocom in the USA or EU will be used for requesting registration approval in China
4. Based on PK, dosing and existing trial results in the USA, Qianjiang and D Graham Burton and Dr Joseph Fortunak will meet with the SFDA to determine what additional data will be required to initiate corresponding trial in China.