BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, has announced that its Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its antifungal agent, miconazole Lauriad, has been allowed by the US FDA.

Miconazole Lauriad is a once-daily 50 mg extended-release Bioadhesive Buccal Tablet being investigated as a 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 denture use. BioAlliance intends to initiate the Phase III trial in the fourth quarter of 2005.

The pivotal Phase III trial will be conducted in HIV-positive patients under the Section 505(b)(2) approval mechanism, allowing for a single Phase III trial based on previous approval of a drug product (miconazole) through reliance upon the FDA's prior findings of safety and efficacy together with third party data on safety and effectiveness available in the published literature. As part of the IND filing, BioAlliance submitted the results of two completed Phase III trials conducted in the EU, one in head & neck cancer patients following radiotherapy and the other in HIV-positive patients.

Dominique Costantini, president and CEO of BioAlliance Pharma said, "With our upcoming registration filing in the EU together with ongoing activities aimed at clinical development in Japan, we are rapidly expanding the potential global market for miconazole Lauriad and, as regulatory approvals are obtained, the possibility of a new treatment option for physicians and their patients suffering from OPC."