BioAlliance Pharma starts pivotal U.S. phase 3 trial of Loramyc treatment for oral fungus

By Lisa Kerner

Erie, Pa., May 16 - BioAlliance Pharma began a pivotal U.S. phase 3 trial for its antifungal agent Loramyc (miconazole Lauriad), a once-daily 50 mg extended-release bioadhesive buccal tablet treatment for the oral fungas oropharyngeal candidiasis (OPC) frequently found within immunocompromised populations.

"The launch of this phase 3 clinical trial clearly signals our plans to develop the North American market with the first product from our Lauriad range," chief executive officer Dominique Costantini said in a company news release.

"Our application for a Marketing Authorization for this product is being processed in France and in Europe via the mutual recognition arrangement."

BioAlliance said that in accordance with the Food and Drug Administration, the pivotal phase 3 trial for the indication oropharyngeal candidiasis will be carried out on a population of HIV-positive patients who have contracted OPC.

The company has carried out two phase 3 trials in Europe, one on patients with cancer of the head and neck after radiotherapy and the other on HIV-positive patients.

Paris-based BioAlliance Pharma develops therapeutics targeting drug resistance in cancer, HIV and severe and opportunistic infections.

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