BioAlliance Pharma announces preliminary results of its Doxorubicin Transdrug® Phase I/II clinical trial for primary liver cancer

BioAlliance Pharma SA (Euronext Paris: BIO), an emerging specialty pharmaceutical company focused on the development of innovative therapeutics targeting drug resistance in cancer, HIV, and severe and opportunistic infections, announced today the presentation of preliminary results from its Doxorubicin Transdrug® Phase I/II clinical trial for primary liver cancer. Dr Jean-François Dufour-Lamartinie, Director of Clinical Research in Oncology at BioAlliance, will present the results at the 12th ISVHLD (12th International Symposium on Viral Hepatitis and Liver Disease) in Paris July 1-5.

"The preliminary results of the trial are very promising and represent an important step for the development of Doxorubicin Transdrug® as we prepare for the Phase II/III trial slated for Q3 2006," said Dominique Costantini, MD, president and CEO of BioAlliance Pharma. "These results are also extremely positive because of their encouraging implications for the future application of our Transdrug® nanotechnology platform."

Doxorubicin Transdrug® has been granted orphan drug status by the EMEA in Europe and the FDA in the USA for the treatment of hepatocellular carcinoma, the most lethal form of liver cancer, and for which no approved treatment exists.

Transdrug® is a treatment based on nanotechnology developed by BioAlliance Pharma. It allows intracellular drug targeting - a recognized medical benefit - to optimize drug efficacy and patient tolerance. Doxorubicin Transdrug® couples this technology with doxorubicin, a chemotherapeutic agent that is powerful and effective against many forms of cancer. In the case of hepatocellular carcinoma, Doxorubicin Transdrug® is injected directly into the liver via a catheter inserted in the hepatic artery.

The Phase I/II clinical trial was carried out in France in the main centers that specialize in liver cancer in the university hospitals of Bordeaux, Clermont-Ferrand, Orléans, Strasbourg, La Pitié Salpêtrière (Paris), Beaujon (Paris) and the Centre hépato-biliaire Paul-Brousse (Paris), under the co-ordination of Professor Christian Trepo, head of the Hepato-Gastroenterology department at the Hôpital de l'Hôtel-Dieu (Lyon) and his assistant Professor Philippe Merle. The main objective for the trial was to determine the maximum tolerated dose that could be used in future clinical trials, and also to evaluate the efficacy of doxorubicin Transdrug®.

During the trial, 20 patients with advanced liver cancer were treated with an injection of doxorubicin Transdrug® into the hepatic artery. The maximum tolerated dose (MTD) in this study was 30mg/m2 and this is the dose that will be used for the clinical development.