The biopharmaceutical company also gives a progress report on its other clinical programs, Loramyc® and acyclovir Lauriad®
Paris, December 14, 2006 -- BioAlliance Pharma SA (Euronext Paris - Code Isin: FR0010095596 - BIO), an emerging specialty pharmaceutical company, announced today that it has received approval from France's medical agency, AFSSAPS, to begin Phase II/III clinical trials for its primary liver cancer treatment doxorubicin Transdrug®.
“Liver cancer is a very aggressive form of cancer for which there is no currently registered specific treatment,” said Dominique Costantini, MD, President and CEO of BioAlliance Pharma. “Doxorubicin Transdrug® has come through all stages of its development with outstanding success and is now entering a trial aimed at preparing product registration. This trial should allow us to evaluate the efficacy and tolerance of doxorubicin Transdrug® and compare it with the existing clinical practice (standard of care).”
This randomized Phase II/III trial will measure the efficacy of doxorubicin Transdrug® delivered by repeated intra-arterial hepatic injection. The efficacy will be measured over the short term in Phase II by the number of patients out of 50 in whom there is no disease progression over a three-month period. The second, Phase III, part of the trial will be extended to 200 patients, and a 12-month evaluation will focus on length of time where disease progression is absent.
If the results confirm the efficacy of this treatment, BioAlliance Pharma expects to register the product in Europe using its orphan drug status already obtained in Europe. The company expects a first submission in Europe during the second half of 2009 provided there are no additional requirements imposed by the regulatory authorities.
The trial will be conducted in an estimated 20 centers in Europe under the coordination o Professor Christian Trepo, head of the Hepato-Gastroenterological service at the Hotel-Dieu hospital in Lyon, and his assistant, Professor Philippe Merle. BioAlliance has obtained agreement to start the trial from the committee for the protection of persons (CPP - ethic committee).
Progress in clinical developments for Loramyc® and acyclovir Lauriad®.
Simultaneously with the doxorubicin Transdrug® program described above, BioAlliance Pharma is currently carrying out a pivotal Phase III trial in the USA with its Loramyc® product for the treatment oropharyngeal candidiasis. This product will enter into the mutual recognition procedure in Europe following the granting of marketing authorization in France in October 2006. The company has also submitted to the regulatory authorities the Phase III protocol for labial herpes treatment acyclovir Lauriad®, and expects to start the pivotal trial in Europe in Q1 2007.
The fact that BioAlliance Pharma will carry out three Phase III clinical trials for three separate products in 2007 is a clear demonstration of the progress made by the company since its IPO in December 2005.
About doxorubicin Transdrug®
BioAlliance has developed a proprietary technology, Transdrug®, 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®. 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®, 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® has demonstrated a preferential distribution in the liver and efficacy in circumventing cancer resistance.
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.
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.
Specialty pharma targets the development and marketing of drugs for specialist markets and selected populations. This business model, unlike that of “big pharma” which targets general medicine, offers faster product development, lower R&D costs, smaller sales teams, and hence higher margins and fast growth.
The Company is developing three broad product ranges based on the Lauriad® mucoadhesive technology which allows an early and prolonged release of therapeutic agents at the site of the disease, the Transdrug® nanoparticle technology designed specifically for intracellular targeting, and a New Chemical Entities program focused on development of new drugs in oncology and HIV.
The Loramyc® (miconazole Lauriad®) 50 mg Mucoadhesive Buccal Tablet has completed two Phase III clinical trials in Europe for treatment of oropharyngeal candidiasis (OPC) in cancer and HIV patients. In October 2006, the company obtained Marketing Authorization for this product in France. A pivotal Phase III trial of Loramyc® is ongoing in the US for the same indication. The company has submitted a Phase III protocol for a second product, acyclovir Lauriad®, an oral herpes treatment. A Phase II/III trial in primary liver cancer (hepatocellular carcinoma or HCC) utilizing the Company's doxorubicin Transdrug® nanoparticle delivery technology has started in Europe. This product 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.
President and CEO
Tel : +33 1 45 58 76 01
|BioAlliance Pharma SA||
Chief Operating Officer
Tel : +33 1 45 58 76 00
Tel: +33 1 53 67 36 33
Tel: +33 1 53 67 35 74
||Andrew Lloyd & Associates||
Juliette DOS SANTOS
Tel: +33 1 56 54 07 00
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