BioAlliance Pharma SA (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 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).