May 15 2012
BioAlliance Pharma SA (Euronext Paris:BIO), a Company dedicated to
orphan oncology products and specialty products, today announces the
initiation of ReLive, its phase III clinical trial with Livatag®
(doxorubicin Transdrug™), as scheduled in the advancement calendar of
the project. This international, multicenter, randomized phase III trial
aims at evaluating the efficacy of Livatag® on overall
survival in nearly 400 patients suffering from Hepato Cellular
Carcinoma, resistant or intolerant to sorafenib.
Almost 15 French sites expert in hepatology are already initiated and
able to start recruiting the first patients. In the short and middle
term, BioAlliance Pharma plans to extend the study to about 30 sites in
France and abroad.
"Primary liver cancer is a particularly severe cancer and the need
for efficacious treatments in advanced stage of the disease is major to
improve patients' survival", declares Pr. Philippe Merle,
Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and
Principal Investigator of the study. "Livatag® represents
a different therapeutic approach, as compared with targeted therapies
currently under evaluation. Its nanoparticle formulation enables Livatag®
to bypass the resistance mechanisms of the tumor cell and assign it an
interesting activity. This clinical trial should confirm it."
The clinical trial batches of Livatag® have been performed by
qualified companies for injectable cytoxic products in nanoparticle
form, in collaboration with the BioAlliance Pharma's team specialized in
industrial development that ensured the transmission of its know-how
specific to nanoparticle Transdrug™ technology, and followed throughout
the process. The clinical batches will be sent to the investigating
sites in the next days.
At last, the European independent Board of experts of the ReLive trial
has met, with Pr. Michel Beaugrand (Jean Verdier University Hospital,
Paris) as President and Pr. Jordi Bruix (Hospital Clinic i Provincial,
Barcelona), as Vice-President. It will perform a regular monitoring of
the study.
"All necessary authorizations and conditions are now in place to
enable us to actually start the ReLive trial; the investigators can now
screen and treat their first patients. The need for alternative
therapeutics in primary advanced liver cancer is crucial and this trial
should enable to establish the efficacy and the tolerance of Livatag®
in this indication. This last step of the product development is now
launched, barely one year after announcement of the phase II preliminary
results, and in line with the expected schedule, this is a substantial
team performance", comments Judith Greciet, CEO of BioAlliance
Pharma. "Livatag® is the leader of
our "Orphan Oncology product" portfolio, core of the Company's growth
strategy, and represents a very strong asset for BioAlliance, with a
sales potential above 800 million Euros. Implementation and realization
of ReLive are indeed key steps to value this Company's strong asset".
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