Alliance Pharma updates on Oxygent

Following a Steering Committee meeting earlier this month in China with its partner Beijing Double-Crane Pharmaceutical, US firm Alliance Pharmaceutical has updated its clinical development plan for Oxygent (perfluorochemical emulsion) to focus primarily on supporting the initial clinical development of the product in China. This means it will investigate Oxygent in maintaining hemodynamic stability during major surgery, thereby potentially reducing or avoiding intraoperative transfusions of donor blood in major surgery.

In addition, the Phase II clinical trial in China will incorporate oxygenation endpoints of postoperative improvement of organ function, such as the gut, heart, brain and kidney. As a result, Alliance will discontinue enrollment in the current French study and evaluate a new protocol to correspond to the China Phase II trial. Alliance is currently transferring the manufacturing technology to enable Double-Crane to produce Oxygent in China.

Following the manufacture of clinical supplies there, the Chinese firm plans to submit an Investigational New Drug application to the local regulator, which is anticipated to be completed in 2008. Alliance will seek additional funding to support this plan.