BioAlliance Pharma Announces Preliminary Results of its Doxorubicin Transdrug(R) Phase I/II Clinical Trial for Primary Liver Cancer
|BioAlliance Pharma Presents 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(R) as we prepare for the Phase II/III trial slated for Q3 2006”
BioAlliance Pharma SA (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(R) Phase I/II clinical trial for primary liver cancer. Dr Jean-Francois 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(R) 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(R) nanotechnology platform."
Doxorubicin Transdrug(R) 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(R) 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(R) 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(R) 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, Orleans, Strasbourg, La Pitie Salpetriere (Paris), Beaujon (Paris) and the Centre hepato-biliaire Paul-Brousse (Paris), under the co-ordination of Professor Christian Trepo, head of the Hepato-Gastroenterology department at the Hopital de l'Hotel-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(R).
During the trial, 20 patients with advanced liver cancer were treated with an injection of doxorubicin Transdrug(R) 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.
About Doxorubicin Transdrug(R)
BioAlliance has developed a proprietary technology, Transdrug(R), using PIHCA (poly-iso-hexyl-cyanoacrylate), a proprietary polymer allowing the realization of nanoparticules mainly with anti-cancer drugs. In the human body, these drug-loaded nanoparticles can be used for delivery of drugs through the intra-arterial, intravenous, or oral route of administration, are translocated into the cancer cell where they can elicit their known anti-cancer activity. Hence the name of the technology: Transdrug(R). Resistance has become a serious problem in cancer treatment, and multi-drug resistance (MDR) at present is the main cause of chemotherapy treatment failure.
Transdrug(R), which is designed to bypass MDR mechanisms, is capable of restoring the sensitivity of cancer cells, overcoming resistance in cancer therapy, and may thereby fill a very important therapeutic gap in cancer treatment (X Pepin 1997).
Hepatocellular carcinomas are particularly resistant to chemotherapeutic agents (E Pang 2005), explaining the very poor prognosis. This resistance is likely the result of multidrug resistance P-glycoproteins and MDR-associated proteins together, physiological pumps rejecting the cytotoxic drug out of the cell, with reduced hepatocellular drug uptake into the tumors (G Zollner 2005).
Doxorubicin Transdrug(R) has demonstrated a preferential distribution in the liver and efficacy in circumventing cancer resistance.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the fifth most common cancer, with an estimated 566,000 people worldwide (Parkin DM, 2001) (about 46,000 cases in Europe and 15,000 cases in the U.S.) diagnosed each year and an almost equal number of people dying from the disease. The 5-year survival rate of HCC is less than 5% without treatment, making it also one of the most deadly diseases. There are currently no approved therapies for the treatment of HCC. The only proven potentially curative therapy is surgical resection or liver transplantation.
The incidence of hepatocellular carcinoma is regularly increasing worldwide, with striking geographical differences observed in both risk factors and occurrence. Particularly, the incidence in developing countries, in East and Southeast Asia (especially in China and Japan) and Sub-Saharan Africa, is many times higher than in developed countries. Chronic infection with the hepatitis B virus (HBV) and hepatitis C virus (HCV) in the etiology of HCC is well established and has played a significant role in the increase of the disease. The increase in hepatitis incidence in Western countries explains the continuing increase of the disease in both Europe and the U.S. In Europe, 28% of HCC cases have been attributed to chronic HBV infection and 21% to HCV infection (Bosch FX, 2000). Other risk factors such as alcohol consumption, may explain the residual variations within countries.
About BioAlliance Pharma
BioAlliance Pharma SA (Euronext Paris: BIO) is an emerging specialty pharmaceutical company focused on the development of innovative therapeutics targeting drug resistance in cancer, HIV, and severe and opportunistic infections. The Company is developing three broad product ranges based on the Lauriad(R) adhesive technology which allows an early and prolonged release of therapeutic agents at the site of the disease, the Transdrug(R) nanoparticle technology designed specifically for intracellular targeting, and a New Chemical Entities program focused on development of new drugs in oncology and HIV.
The Company's most advanced product, the Loramyc(R) (miconazole Lauriad(R)) 50 mg Bioadhesive Buccal Tablet, has completed two Phase III clinical trials in Europe for treatment of oropharyngeal candidiasis (OPC) in cancer and HIV patients. In September 2005, BioAlliance filed a request for Marketing Authorisation (MAA) in Europe for this product. Under an IND allowed by the US Food and Drug Administration (FDA), a pivotal Phase III trial of Loramyc(R) is ongoing in the US in 2006 for the same indication. A second product, acyclovir Lauriad(R), for the treatment of oral herpes, has completed a Phase I clinical trial in Europe. A Phase I/II trial in primary liver cancer (hepatocellular carcinoma or HCC) utilizing the Company's doxorubicin Transdrug(R) nanoparticle delivery technology is ongoing in Europe, and has been granted orphan drug status by the EMEA and the FDA.
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements please refer to the Risk Factors (Facteurs de Risque) section of the reference document approved by the AMF on 28 April 2006 under the number R. 06-042, which is available on the AMF website http://www.amf-france.org or BioAlliance Pharma S.A.'s website http://www.bioalliancepharma.com.