Initiation of ReLive, phase III clinical trial with Livatag® In primary liver cancer

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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