SAN DIEGO, Feb. 6 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical
Corp. (OTC Bulletin Board: ALLP) 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.
SOURCE Alliance Pharmaceutical Corp.
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Related links:
http://www.allp.com/
CONTACT:
Renee Roth of Alliance Pharmaceutical Corp.,
+1-858-410-5231
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