BioAlliance Pharma starts pivotal Phase III clinical trial in the US of Loramyc® treatment for oropharyngeal candidiasis
17 May 2006
BioAlliance Pharma (Euronext 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® (miconazole Lauriad®). 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® 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."