Phase II clinical trial results of Doxorubicin Transdrug announced

BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces positive survival data in its phase II clinical trial with doxorubicin Transdrug® in patients with advanced hepatocellular carcinoma (primary liver cancer).

Doxorubicin Transdrug®, a treatment presented in the form of nanoparticles delivered via hepatic intra-arterial route, was granted an orphan drug status in Europe and in the United States. The product is being evaluated in patients with advanced hepatocellular carcinoma, one of the leading causes of mortality in cancer.

BioAlliance Pharma phase II results showed a 88.9% survival rate after 18 months of treatment in patients having received three intra-arterial doxorubicin Transdrug® injections, as per protocol. This increased survival rate is relevant compared to the 54.5% rate observed in patients with the current standard of care (usually transarterial chemoembolisation with a cytotoxic drug).

Based on these data, BioAlliance Pharma will design new approaches using doxorubicin Transdrug® while reducing pulmonary adverse events that led to the suspension of the trial.

“BioAlliance Pharma is capitalizing on its proprietary Transdrug® nanotechnology by developing oral drug formulations”, said Dominique Costantini, President and CEO of BioAlliance Pharma. “We are applying this innovative know-how to the treatment of various cancers using oral irinotecan nanoparticles instead of intravenously administration. BioAlliance Pharma aims at improving the irinotecan’s risk-benefit ratio and has recently presented positive preclinical data at several international symposia”, added Dominique Costantini.

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