PARIS -- 07/16/08 --
BioAlliance Pharma suspends the Phase II/III trial of
doxorubicin Transdrug® in primary liver cancer, following advice from the
Drug Safety Monitoring Board and the Steering Committee
Paris, July 16th, 2008 - BioAlliance Pharma SA (Euronext Paris -BIO), the
specialty pharmaceutical company focused on the treatment of opportunistic
infections in cancer and HIV, announced today the suspension of its Phase
II trial of doxorubicin Transdrug® in primary liver cancer. The company
is following advice (as set out in the study schedule) provided by the Drug
Safety Monitoring Board and the Steering Committee, which have been
continuously monitoring the trial's progress. On the basis of the initial
data, the two committees observed a clinical benefit but also more frequent
and more severe pulmonary adverse events than expected and have thus
recommended suspension of the trial, given the incidence of this type of
effect.
This type of acute pulmonary damage was observed in Phase I/II trial at a
dose of 35mg/m2 (the maximum tolerated dose) but had not been observed at
30mg/m2, the dose chosen for repeated administrations in the next
development phase.
In this Phase II trial, doxorubicin Transdrug® was being compared with
the current standard of care (a control group undergoing Trans-Arterial
Chemo-Embolization).
In terms of the criteria for assessing the efficacy and safety of repeated
intra-arterial hepatic injection of doxorubicin Transdrug®, the efficacy
endpoint was based on progression-free survival after 3 months of
treatment.
"Non-operable primary liver cancer in cirrhotic patients has a very poor
prognosis. There are few effective treatments, and it is therefore
important to evaluate the benefit/risk ratio of therapeutic innovations,"
stated Dominique Costantini, BioAlliance Pharma's co-founder, President and
CEO. "We scheduled Drug Safety Monitoring Board and Steering Committee
meetings into the trial's timeline and we have been following their
recommendations".
Our product portfolio is based on independent innovations, and each has its
own risks. This allows us to redirect our focus so if this trial has to be
suspended permanently, we shall bring another compound into the clinical
phase," added Dominique Costantini.
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 already received European Marketing Authorizations in UK,
Germany, Belgium, Denmark and Luxemburg. The compound has completed the
pivotal 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 infectious disease markets.
In 2007, the company has established strategic alliances for
commercializing Loramyc® in Europe (with JV SpeBio) and in the USA with
Par Pharmaceutical. In March 2008, BioAlliance Pharma signed a partnership
agreement with Handok Pharmaceuticals for commercializing Loramyc® in
Korea, Taiwan, Singapore and Malaysia and with Novamed Pharmaceuticals in
June 2008 for commercialization of Loramyc(TM) in China. In May 2008, the
company expanded its product portfolio via acquisition of the European
commercial rights to ondansetron Oral Spray (OS) from NovaDel Pharma Inc.
(Amex: NVD).
For more information, visit BioAlliance Pharma's website at
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 11 2008 under the number R. 08-021, which is available
on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma
S.A.'s website (http://www.bioalliancepharma.com).
BioAlliance Pharma SA
Dominique Costantini, President and CEO
Tel.: +33 1 45 58 76 01
dominique.costantini@bioalliancepharma.com
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
nicolas.fellmann@bioalliancepharma.com
ALIZE RP
Caroline Carmagnol
Tel.: +33 6 64 18 99 59
caroline@alizerp.com
This information is provided by HUGIN
