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Home » BIOALLIANCE ANNOUNCES POSITIVE DATA ON LIVER CANCER TREATMENT
BIOALLIANCE ANNOUNCES POSITIVE DATA ON LIVER CANCER TREATMENT
September 22, 2006
BioAlliance Pharma has announced that the Phase I/II l trial of its doxorubicin Transdrug for primary liver cancer has shown positive results. The main objective of this clinical trial was to determine the drug's maximum tolerated dose, which can be used in subsequent clinical trials, and secondly to measure the efficacy of doxorubicin Transdrug. During the trial, 20 patients suffering from advanced liver cancer received at least one intra-arterial hepatic injection of doxorubicin Transdrug. Tolerance and efficacy data from this trial resulted in the selection of a 30-mg/m2 dose to be used for further clinical development of the treatment.
In the sub-group of patients who received the 30-mg/m2 dose, the efficacy measurements show promising results for the treatment with an objective response of 16.67 per cent after a single injection. After a centralized radiological review showed disease control in 60 percent of patients, with five partial responses and seven stabilizations.
BioAlliance developed Transdrug using PIHCA, a proprietary polymer allowing the realization of nanoparticles mainly with anti-cancer drugs. These drug-loaded nanoparticles can be used for intra-arterial, intravenous or oral delivery of drugs, and they are then translocated into the cancer cell where they can elicit their known anti-cancer activity. Doxorubicin Transdrug has demonstrated a preferential distribution in the liver and efficacy in circumventing cancer resistance. The treatment has been granted orphan drug status in Europe and in the U.S. for the treatment of hepatocellular carcinoma.
KEYWORDS Drug Pipeline Alert
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