Submission of a phase III clinical trial application for Livatag® in the treatment of primary liver cancer to the French Drug Agency (Afssaps).

BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), a company dedicated to specialty and orphan oncology products, today announces the submission of a phase III clinical trial application for Livatag® in the treatment of primary liver cancer to the French Drug Agency (Afssaps).

This application follows the phase II survival data announced by BioAlliance Pharma in March 2011 and showing a doubled median survival in Livatag® treated patients (32 months, to be compared with 15 months for patients treated with best of care TACE transarterial chemoembolisation with a cytotoxic drug). This 17 months difference in survival strongly reinforces the interest in the product and justifies a phase III clinical trial application.

These results have been accepted for oral communication at the International Liver Cancer Association (ILCA) 2011 congress.

Moreover, BioAlliance has validated a new administration regimen in animal models, which significantly reduces acute pulmonary adverse events. The phase II trial had been hold in July 2008 due to pulmonary toxicity, whereas patients' survival has been followed up, upon request from the independent study Drug Safety Monitoring Board.

" The survival data jointly with the validated administration scheme aiming to prevent acute pulmonary adverse events justify to re-open the dialog with the French Drug Agency, for a phase III clinical trial that could be initiated in 2012", comments Pierre Attali, COO, Strategy and Medical Affairs of BioAlliance Pharma.

"This application represents a major step within the final development stage of Livatag® before registration, as it has been granted an orphan drug status. The primary liver cancer still represents a high unmet medical need in terms of survival. The global potential turnover of such a product can be evaluated between 800 million and 1 billion Euros. We expect a launch on the market in a 3 to 5 years time, according to the clinical trial results, either through international partnerships, or through direct commercialization in Europe", comments Judith Greciet, COO, Operations & R&D.

About Livatag®

Primary liver cancer, or hepatocellular carcinoma, is the fifth cancer in incidence and the third leading cause of cancer deaths worldwide. This cancer is highly chemo-resistant, very often diagnosed at an advanced stage and still represents a high unmet medical need.

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.

Livatag® is today the leader in the orphan oncology products portfolio, also including clonidine Lauriad™ in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer (phase II) and AMEP® in metastatic melanoma (phase I).

Source:
BioAlliance Pharma
International Liver Cancer Association
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