Alliance Pharmaceutical Corp. previously reported that recently produced clinical supplies of Oxygent(TM) would be used by Alliance's partner in China, Beijing Double-Crane Pharmaceutical Co. Ltd. (Double-Crane), for Double-Crane's Investigational New Drug (IND) application to the State Food and Drug Administration P.R. China (sFDA).

In accordance with the current regulations of sFDA, the supplies for the IND application and clinical development must be manufactured in a facility in China. As a result, Alliance has agreed to accelerate the technology transfer to Double-Crane, which originally was planned to occur when Phase 3 trials were initiated in China.

Because Double-Crane has considerable experience in manufacturing large-volume parenteral and IV solutions, Double-Crane has indicated to Alliance that it believes production of the relevant clinical supplies can begin in an expeditious manner. Double-Crane has also expressed a desire to supply Alliance with clinical and commercial supplies of Oxygent from its facilities, which would be contingent on Double-Crane's compliance to Current Good Manufacturing Practices (cGMP) and registration with the U.S. FDA.

Once clinical supplies are manufactured by Double-Crane, Double-Crane has indicated that it will submit its IND application for initiation of the agreed upon clinical development plan. Once sFDA approves the application, Double- Crane will start the clinical trials immediately.

Double-Crane intends to pursue an intra-operative and post-operative transfusion avoidance endpoint as the primary endpoint. Double-Crane's clinical development plan would incorporate a new protocol design which is intended to build on the previously conducted Alliance Phase 2 and Phase 3 clinical trials.

Double-Crane is obligated pursuant to its agreement with Alliance to conduct clinical trials in China in accordance with International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines, which would allow Alliance to use any data derived from the clinical trials in other countries.

Source:佚名