BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to specialty and orphan oncology products, today announces oral communication of the Phase II clinical trial results of its orphan product Livatag® at the annual congress of ILCA (International Liver Cancer Association), the only international organization devoted exclusively to liver cancer research with participation of worldwide best specialists.
Pr. Philippe Merle, Professor of hepatology at the Hospices Civils de Lyon and principal investigator of the Phase II trial, presented preliminary survival results observed in patients with unresectable hepatocellular carcinoma (primary liver cancer). Out of the total 50 patients planned, 28 were randomized and have received intra-arterial injection of Livatag® (n=17) or chemoembolization (n=11), according to a 2/1 scheme (2 patients with Livatag® for 1 patient with chemoembolization). Livatag® was administered every 4 weeks, up to 3 injections.
Although the trial had been put on hold due to severe pulmonary adverse events, the assessment of survival has been continued based upon the recommendation of the Independent Data Safety Monitoring Board.
The survival results for patients treated with Livatag® showed a significant increase compared to the control group with 31.7 months median survival versus 15 months (p<0.05). Patients who received 3 injections had an even better response with an increased median survival (33 versus 15 months) (p<0.05).
Pr. Philippe Merle concluded on the promising opportunities offered by the new slow intravenous administration route, enabling a better control of pulmonary effects, considering the substantial survival benefits showed in a pathology where therapeutic solutions are rare.
These results have also been accepted for a presentation during the AFEF (Association Française pour l’Etude du Foie) congress in Paris, from September 28 to October 1, 2011.
« Livatag® is the leading product of our « orphan oncology products » portfolio that comprises also two other products in clinical phase (clonidine Lauriad™ in phase II in the treatment of mucositis and AMEP™, in phase I in the treatment of metastatic melanoma)”, declared Judith Greciet, CEO of BioAlliance Pharma. “This development strategy in an orphan disease is a key driver of the Company growth. The strong interest for Livatag® from the scientific and medical community confirms our choice to expand in such area where there is a crucial medical need”.
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).
The Association Française pour l’Etude du Foie is a medical society that promotes the development of hepatology in France and in French speaking countries through scientific meetings among hepatologists and publications.