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BioAlliance Pharma announces final results of its doxorubicin Transdrug Phase I/II clinical trial for primary liver cancer

20 Sep 2006

Specialty pharma company presents encouraging results at the 7th international conference of the Asian Clinical Oncology Society, September 14-18 in Beijing

PARIS, France | Sep 19 2006 | BioAlliance Pharma SA (Euronext Paris - Code Isin : FR0010095596 - 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 that the Phase I/II clinical trial of its doxorubicin Transdrug(R) for primary liver cancer has produced encouraging results. Dr Jean-François Dufour-Lamartinie, Director of Clinical Research in Oncology at BioAlliance, presented these results at the 7th international conference of the Asian Clinical Oncology Society (ACOS), September 14-18 in Beijing.

"Doxorubicin Transdrug(R) offers a promising therapeutic alternative to patients suffering from this very aggressive type of liver cancer for which no satisfactory therapy is currently available," said Dominique Costantini, MD, president and CEO of BioAlliance Pharma. "The positive results of this clinical trial give us an excellent incentive to continue the development of this product and of our Transdrug(R) platform for this and other indications."

The main objective of this Phase I/II clinical trial was to determine the maximum tolerated dose which can be used in subsequent clinical trials and secondly to measure the efficacy of doxorubicin Transdrug(R).

During the trial, 20 patients suffering from advanced liver cancer received at least one intra-arterial hepatic injection of doxorubicin Transdrug(R). Tolerance and efficacy data from this trial resulted in the selection of a 30mg/m2 dose to be used for further clinical development of the treatment.

In the sub-group of patients who received the 30mg/m2 dose, the efficacy measurements show promising results for doxorubicin Transdrug(R) with an objective response of 16.67 per cent after a single injection. A recent study presented to the American Society of Clinical Oncology gastro-intestinal meeting earlier in 2006 showed an objective response of only four per cent to intravenous injections of doxorubicin in patients with advanced liver cancer. After a centralized radiological review, the disease showed a disease control in 60 per cent of patients (disease control in 12 out of 20 patients) with five partial responses and seven stabilizations. 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.

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 nanoparticles 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. 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.

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 Authorization (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 has been completed in Europe, and has been granted orphan drug status by the EMEA and the FDA.

Disclaimer 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. -- Neil Hunter ANDREW LLOYD & ASSOCIATES http://www.ala.com This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

SOURCE: BioAlliance Pharma SA

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