Livatag follow up demonstrates significant survival increase in advanced hepatocellular carcinoma patients
BioAlliance Pharma SA announced the update of its preliminary positive survival data with Livatag® (doxorubicin Transdrug™).
Livatag® is a treatment presented in nanoparticles able to deliver doxorubicin in chemoresistant cells. Livatag® was granted an orphan drug status in Europe and in the United States. The product is being evaluated in patients (via hepatic intra-arterial route) with advanced hepatocellular carcinoma, described as highly chemoresistant. Hepatocellular carcinoma (primary liver cancer) is the third cause of cancer mortality worldwide.
BioAlliance Pharma phase II follow up results showed a median survival of 32 months for Livatag® group, as compared with 15 months for patients getting current best of care (TACE transarterial chemoembolisation with a cytotoxic drug). This significant 17 months difference in the median survival is the basis for strong renewed interest in the product while on clinical hold.
BioAlliance Pharma is also pleased to announce the successful development of proprietary new Intravenous administration of Livatag® validated in animal models, which reduces acute pulmonary adverse events that led to the clinical hold. Livatag® new administration rationale jointly with the survival benefit observed will be presented to the French Drug Agency by Q2 2011. The company intends to communicate the final complete data in a specialized international congress.
“We believe that these new achievements are paving the way for a constructive dialog with health authorities, taking into account the impressive survival benefit in this severe resistant disease. Livatag® is perfectly in line with our orphan product strategy and could be a significant value catalyst for the company” said Dominique Costantini, CEO of BioAlliance Pharma.
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