SAN DIEGO, Feb. 6 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical Corp. today announces the manufacture and release for shipment of Oxygent (TM) (perfluorochemical [PFC] emulsion) for clinical trials.
The clinical supplies will be used in the Phase 2 Proof of Concept trial that will be conducted in Europe and by Alliance's partner in China, Beijing Double-Crane Pharmaceutical Co. Ltd. (Double-Crane), for its Investigational New Drug (IND) application to the State Food and Drug Administration P.R. China (sFDA).
About the Phase 2 clinical trial in Europe:
On December 18, 2006, Alliance announced that the French Competent Authority (regulatory agency) approved the start of the Phase 2 clinical trial for Oxygent to prevent post-op ileus resulting from hypoxia during major surgery trial. Subsequently, Alliance has submitted a clinical trial protocol revision to the French Ethics Committee and the French Competent Authority that modifies the dosing regimen to a dose-escalation protocol. This modification allows for the safety and efficacy to be evaluated at three dose levels. This modification potentially could add additional 30-60 patients to the trial, depending upon the evaluation of efficacy at each dosing level. Alliance has enough funds to complete the first dose level and may need to raise additional funding if all three dose groups need to be evaluated.
About the clinical development program in China:
Following the sFDA review, which Double-Crane estimates to be six-nine months, Double-Crane will be able to initiate the clinical development program for Oxygent in China, starting with its Phase 1 safety study. Approval from the sFDA to begin the study triggers a milestone payment to Alliance. Double- Crane will 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 will allow Alliance to use any data derived from the clinical trials in other countries.
Double-Crane will be pursuing a transfusion avoidance indication in its Territories with a new protocol design based on knowledge gained by Alliance from previous clinical trials conducted in the U.S. and in Europe. In these studies, the efficacy of Oxygent in terms of drug activity, i.e., its ability to deliver oxygen, the establishment of the hemoglobin (Hb) equivalency of a dose of Oxygent (a 2.7 g/kg clinical dose of Oxygent is equivalent to ~ 4 g/dL [Hb]), and the ability of Oxygent to enable patients to be physiologically stable and safe at lower intraoperative Hb levels, was demonstrated. Unlike these previous studies, the Phase 2 and 3 studies to be conducted by Double- Crane will be without autologous blood conservation procedures such as Acute Normovolemic Hemodilution (ANH) or Intraoperative Autologous Donation (IAD) used in previous clinical studies. The use of Oxygent without ANH would avoid the need to treat patients prophylactically before knowing the extent of surgical blood loss, and potentially simplify its use and facilitate the acceptance of Oxygent in the marketplace.
About Alliance Pharmaceutical Corp.:
Alliance Pharmaceutical Corp. is a development-stage pharmaceutical company that is currently focused on developing its lead product, Oxygent, which is based on its proprietary PFC technology. Oxygent is being developed as an intravascular oxygen carrier designed to augment oxygen delivery in surgical patients.
Except for historical information, the matters set forth in this release are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth herein. Alliance refers you to cautionary information contained in documents Alliance files with the Securities and Exchange Commission from time to time, including the last Form 10-KSB and Form 10-QSB. Alliance is under no obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.
Alliance Pharmaceutical Corp.