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BioAlliance Pharma Starts Pivotal Phase III Clinical Trial in the US of Loramyc(R) Treatment for Oropharyngeal Candidiasis

16 May 2006

PARIS, France | May 16, 2006 | BioAlliance Pharma(ISIN:FR001009559)(PARIS:BIO), an emerging specialty pharmaceutical

company, announced today the start of a pivotal Phase III trial in the US for its antifungal agent, Loramyc(R) (miconazole Lauriad(R)). BioAlliance Pharma develops innovative therapeutics targeting drug resistance in cancer, HIV, and severe and opportunistic infections.

"The launch of this Phase III clinical trial clearly signals our plans to develop the North American market with the first product from our Lauriad(R) range," said Dominique Costantini, CEO of BioAlliance Pharma. "Our application for a Marketing Authorisation for this product is being processed in France and in Europe via the mutual recognition arrangement. Together with the US these regions cover about 80 per cent of the potential market."

Loramyc is a once-daily 50 mg extended-release Bioadhesive Buccal Tablet first-line local treatment for oropharyngeal candidiasis (OPC), an oral fungus. OPC infections are frequent within immunocompromised populations, such as those represented by cancer therapy, HIV-infection, ICU and transplant patients, diabetes mellitus, and those in old age.

In accordance with FDA, the indication will be Oropharyngeal candidiasis and the pivotal Phase III trial will be carried out on a population of HIV-positive patients who have contracted OPC. The trial should allow the product to be registered. BioAlliance has already carried out two Phase III trials in Europe, one on patients with cancer of the head and neck after radiotherapy, and the other on HIV-positive patients.

"We have assembled an American panel of scientific experts and clinical investigators for this trial, including the professors L. Patton, M. A. Gannoum and J. Epstein," said Gilles Avenard, chief operating officer of BioAlliance Pharma. "They are all at the highest levels of their profession and include the major clinical centers specialised on the oral pathologies of immunocompromised patients."

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. 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.

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.

SOURCE: BioAlliance Pharma SA

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