SAN DIEGO, Nov. 7 /PRNewswire-FirstCall/ -- Alliance Pharmaceutical
Corp. (OTC Bulletin Board: ALLP) today announces the following update with
regard to the development of Oxygent(TM) (perfluorochemical (PFC) emulsion)
to prevent post-op ileus resulting from hypoxia during major surgery.
Earlier this year, Alliance reported that the German Competent
Authority (regulatory agency) completed its review and approved the start
of the Phase 2 clinical trial for Oxygent to prevent post-op ileus
resulting from hypoxia during major surgery; however, the relevant German
Ethics Committee responded with a negative vote on the protocol based upon
risk/benefit in the cardiac patient population selected. Alliance appealed
the negative decision, and offered additional clarifications and supporting
data for the protocol, but the German Ethics Committee has informed us that
it has declined approval of the study protocol as submitted. Alliance is
now proceeding to explore other options available in Germany, one of which
may be the submission of a revised protocol.
The French Competent Authority is continuing its consideration of our
submission and we have responded to several of its review questions. The
relevant French Ethics Committee has approved the start of the trial. We
believe that if we receive the Competent Authority approval by the end of
the calendar year, we could initiate and complete the clinical trial in
2007. We estimate that we have sufficient funds to implement this scenario.
If significant adjustments need to be made to the protocol to make it
acceptable for approval, then we may need additional funds to complete the
study.
In addition, Alliance has successfully completed the technology
transfer to its contract manufacturer for the production of clinical trial
material. Clinical supplies are currently being produced to meet the
requirements of the above clinical studies and to supply our partner in
China, Beijing Double-Crane Pharmaceutical Co. Ltd. (Double-Crane). We
anticipate that Double-Crane will complete their submission to the sFDA and
initiate their clinical development of Oxygent in 2007.
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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CONTACT: Corporate Communications of Alliance Pharmaceutical Corp., +1-858-410-5275
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