BioWorld International Correspondent
PARIS - BioAlliance Pharma SA received the go-ahead from the French Health Products Safety Agency (AFSSAPS) to conduct a Phase II/III trial of its doxorubicin Transdrug in primary liver cancer.
The Paris-based company reported the final results of a Phase I/II trial in liver cancer in September and plans to launch the next one as quickly as possible.
Pointing out that there is no specific treatment registered for this "naturally very resistant cancer," said BioAlliance's CEO, Dominique Costantini, "Doxorubicin Transdrug has successfully completed all the stages of its clinical development and is now entering a trial whose purpose is the registration of the product. The launch of this trial should enable us to evaluate the efficacy and tolerability of doxorubicin Transdrug in comparison with the existing standard of care."
The drug is administered by intra-arterial injection in repeated courses of treatment, and in the initial Phase II stage of the trial its efficacy will be assessed on the number of patients (50) whose disease has not progressed after three months. In the second, Phase III stage, the trial will be extended to 200 patients and evaluation will be based on the criterion of time without progression over a 12-month period.
If the trial confirms the efficacy of the drug, BioAlliance plans to file doxorubicin Transdrug for regulatory approval in Europe on the fast-track basis provided for under the orphan drug status granted it by the European Medicines Agency for hepatocellular carcinoma, the most fatal form of liver cancer. The compound also has been granted orphan drug designation by the FDA.
BioAlliance is specialized in the development of therapeutics to treat drug resistance in cancer, HIV and severe, opportunistic infections. Transdrug is a proprietary nanotechnology that allows intracellular drug targeting for optimal efficacy and tolerability, while doxorubicin is a chemotherapeutic agent that has proved effective in treating many forms of cancer.