LIVATAG®
Primary liver cancer
Hepatocellular carcinoma (primary liver cancer) is the fifth most common cancer in terms of incidence (750,000 – 800,000 new cases per year) and the third leading cause of cancer deaths worldwide. It occurs in 80-90% of cases in patients with liver cirrhosis mainly due to viruses (virus B and C), alcohol or metabolic syndrome. It is a highly chemotherapy-resistant cancer, often diagnosed at an advanced stage and for which there is a very strong unmet therapeutic need today.
The product
Livatag® is a nanoparticle formulation of doxorubicin (Transdrug™ technology) developed for the treatment of primary liver cancer.
Transdrug™ technology uses nanoparticles to help fight against chemotherapy resistance, a major mechanism in the failure of some anticancer drugs, that facilitate the penetration of the drug into the tumor cell and increase the cellular exposure to the drug.
Livatag® uses this technology along with doxorubicin in the treatment of advanced primary liver cancer. It allows bypassing the mechanisms of multi-drug resistance developed by tumour cells. Encapsulated in the form of nanoparticles, doxorubicin can then reach its therapeutic target and exert its cytotoxic activity.
The Phase II clinical trial has shown that intra-arterial administration of Livatag® increased survival time of patients suffering from hepatocellular carcinoma by 17 months, as compared with15 months for patients getting current best of care (TACE transarterial chemoembolisation with a cytotoxic drug).
Based on this data, an international open randomised Phase III clinical trial (ReLive) comparing repeated intravenous administration of Livatag® to the best standard of care has been implemented in 400 patients with advanced stage hepatocellular carcinoma, after failure or intolerance to sorafenib. A committee of independent experts regularly reviews the tolerance of the treatment administered.
Livatag®, the leader of the Orphan Oncology Products and core of BioAlliance Pharma’s growth strategy, has obtained orphan drug status in two major territories, Europe and the USA, thus enhancing the value of this key asset for the Company.