BioAlliance Pharma presents orphan drug survival results at international liver cancer congress

BioAlliance Pharma SA announces oral communication of the phase 2 clinical trial results of its orphan product Livatag at the annual congress of ILCA (International Liver Cancer Association).

Prof Philippe Merle, Professor of hepatology at the Hospices Civils de Lyon and principal investigator of the phase 2 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).

Prof 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.