SAN DIEGO, Dec. 18 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical
Corp. (OTC Bulletin Board: ALLP) today announces the approval from the
French Competent Authority to allow the start of the Phase 2 clinical trial
for Oxygent(TM) (perfluorochemical [PFC] emulsion) to prevent post-op ileus
resulting from hypoxia during major surgery.
Earlier this year, Alliance reported that the French Ethics Committee
(Investigational Review Board) had approved the start of the trial and that
the French Competent Authority (regulatory agency) was considering
Alliance's response to its review questions. That review has been completed
and the approval was granted to start the trial. Alliance intends to begin
the trial in the first quarter of 2007.
Alliance, through its contract manufacturer, is currently manufacturing
the supplies needed for the above mentioned clinical trial, as well as
those needed for its partner, Beijing Double-Crane Pharmaceutical Co. Ltd.,
to complete Double-Crane's submission to the sFDA and initiate its clinical
development plan for Oxygent in China.
About the clinical indication for the Phase 2 Proof of Concept study:
During major surgery, the body often reacts by decreasing blood flow to
intra abdominal tissues, thereby conserving blood flow and oxygen supply to
vital organs, such as the heart and brain. As a result, gastrointestinal
organs receive less oxygen and postoperative bowel function may be
impaired.
PFC emulsions have been shown to improve oxygenation to organs and
tissues. Clinical evidence for intestinal mucosal protection was obtained
during an Oxygent Phase 3 study in which gastric tonometry was performed in
a subset of patients at one clinical study site, measuring differences
between carbon dioxide tensions in the arterial blood and those in the
tonometer balloon (the "CO2 gap"). During cardiopulmonary bypass, control
patients had elevated CO2 gaps and calculated intestinal mucosal pH
statistically significantly higher than patients treated with Oxygent, in
which these values were normal. This benefit translated into significantly
shorter postoperative time to first bowel movement (2 vs. 5 days; p <
0.007) and a strong trend to earlier consumption of solid food (1.8 vs. 4.1
days; p = 0.056) (Frumento et al. Anesth Analg 2002;94 809-14). These
clinical endpoints, time to recovery of upper gastrointestinal function
(consumption of solid food) and lower gastrointestinal function (bowel
movement), have been accepted by FDA, as approvable endpoints for Adolor
Corporation's Entereg(R) (alvimopan) and Progenics Pharmaceuticals'
methylnaltrexone for postoperative ileus associated with opioid analgesics.
About Alliance Pharmaceutical Corp.:
Alliance Pharmaceutical Corp., founded in 1989, 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:
Corporate Communications of Alliance
Pharmaceutical Corp., +1-858-410-5275
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