SAN DIEGO, March 15 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical
Corp. (OTC Bulletin Board: ALLP) previously reported that recently produced
clinical supplies of Oxygent(TM) (perfluorochemical [PFC] emulsion) 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. In these studies, the efficacy of Oxygent in terms of drug
activity, i.e., its ability to deliver oxygen which enabled patients to
remain physiologically stable at lower intra-operative Hb levels, was
statistically demonstrated to be better than blood. Importantly, the
Double-Crane study will not employ any blood harvesting techniques (i.e.,
acute normovolemic hemodilution or intra-operative autologous donation),
which were implicated in safety issues in a previous Alliance Phase 3
clinical trial.
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.
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.
SOURCE Alliance Pharmaceutical Corp.
back to top
CONTACT: Corporate Communications of Alliance Pharmaceutical Corp., +1-858-410-5275
|