27.12.2007 20:30:00
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BioAlliance Pharma Provides Information on a Press Release Received from Immtech Pharmaceuticals
Regulatory News:
BioAlliance Pharma SA (Paris:BIO) announces that it has just received
the following press release from Immtech Pharmaceuticals, Inc. , the US
company from which it has licensed the European rights for pafuramidine:
"NEW YORK, Dec. 26 -- Immtech
Pharmaceuticals, Inc. (The "Company”)(Amex:IMM)
announced today that it is working with clinical investigators at one
South African site where a single safety study is in progress for
pafuramidine (DB289), an investigational therapy. In preliminary
findings from this study, abnormal laboratory values were found in
volunteers following treatment with pafuramidine. The Company has
discussed the preliminary findings with the U.S. Food and Drug
Administration (USFDA), and as a precautionary measure, the pafuramidine
program has been placed on clinical hold. The clinical hold may be
released after FDA has received satisfactory data regarding the safety
of pafuramidine. Volunteers in this single South African safety study
were either dosed with pafuramidine 100 mg twice daily for 14 days or
placebo. The subjects are undergoing close monitoring for any changes in
the status of their liver function. No subject has required any
treatment or hospitalization for the abnormalities. The Company's
Chairman and Chief Executive Officer Eric L. Sorkin stated, "Our primary
concern is the safety of the patients. We are working closely with
independent experts and the Data Safety Monitoring Board for
pafuramidine." Carol Olson, M.D., Ph.D., Senior Vice President of Pharmaceutical
Development and Chief Medical Officer of Immtech, stated, "This
evaluation will continue until patients stabilize or return to baseline
status. At that time, Immtech and the independent experts in liver
toxicity will prepare a summary of the available safety data and
recommendations for presentation to the FDA.”
This one South African study involving healthy volunteers is being
conducted in one location to collect additional safety data regarding
pafuramidine to support the indications of Pneumocystis pneumonia and
African sleeping sickness. This study was planned in 2005, after
discussions with USFDA, in order to provide a safety database of
appropriate size for submission of these indications to regulatory
authorities. These two diseases affect a relatively small number of
patients (they are considered as orphan drug indications) and so there
are fewer patients available than are generally required for Phase three
trials. This study was designed to increase the number of subjects
treated with pafuramidine.”
After reviewing the available safety data and recommendations,
BioAlliance Pharma will decide whether or not to go ahead with the
product. BioAlliance's financial exposure is limited to the $3 million
paid on signature. Furthermore, BioAlliance Pharma, with no less than
three of its own products already in Phase III clinical trials, is
pursuing its advanced compound acquisition policy with a view to
building a mature portfolio dedicated to the treatment of opportunistic
infections in cancer and AIDS.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on
the treatment of opportunistic infections in cancer and HIV. The company
develops and commercializes innovative products which address resistance
issues. The company has launched its first portfolio product (Loramyc®)
in France and the compound is currently in Phase III clinical
development in oropharyngeal candidiasis in the USA. In addition, two
other innovative products are currently in Phase III clinical trials:
acyclovir Lauriad® in oral herpes (based on
the same Lauriad® muco-adhesive technology as
Loramyc®, which enables targeted release at
the disease site) and doxorubicin Transdrug®
in primary liver cancer (based on the Transdrug®
nanoparticle technology, designed specifically for intracellular
targeting of resistant cells). The company is also developing a new
therapeutic entities program focused on the oncology and HIV markets.
In 2007, the company has established strategic alliances for
commercializing Loramyc® in Europe (with JV
SpeBio) and the USA (with Par Pharmaceutical). For more information,
visit www.bioalliancepharma.com.
Disclaimer This communication expressly or implicitly contains certain
forward-looking statements concerning BioAlliance Pharma SA and its
business. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results,
financial condition, performance or achievements of BioAlliance Pharma
SA to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
BioAlliance Pharma SA is providing this communication as of this date
and does not undertake to update any forward-looking statements
contained herein as a result of new information, future events or
otherwise. For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of BioAlliance
Pharma SA to differ from those contained in the forward-looking
statements, please refer to the Risk Factors ("Facteurs de Risque")
section of the reference document approved by the AMF on April 6th
2007 under the number R. 07-031, which is available on the AMF website (http://www.amf-france.org)
or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com). For press releases and other company information, visit www.bioalliancepharma.com.
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