BioAlliance Pharma Announces Preliminary Phase III Data On Miconazole Lauriad Bioadhesive Buccal Tablets For Local Treatment of Oropharyngeal Candidiasis in Head and Neck Cancer Patients Following Radiation Therapy
1/4/2004 Paris, France press release Business Wire BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, today announced significant positive results from its confirmatory Phase III pivotal study of the miconazole Lauriad(R) 50mg Bioadhesive Buccal Tablet. The results concerned the treatment of oropharyngeal candidiasis in head and neck cancer patients following radiotherapy. The study demonstrates the potential efficacy and safety of a new formulation of miconazole administered as a bioadhesive extended release buccal tablet. The tablet contained 10 times less active drug compared to the same drug applied in a topical gel for treatment of oropharyngeal candidiasis, an oral fungus commonly found in immuno-compromised patients, including HIV and cancer patients, diabetics and the elderly. With the EU clinical program now completed, the results of this investigation together with a previously completed supportive Phase III study in HIV-positive patients will form the basis of a registration filing in the EU in early 2005. An IND to conduct a pivotal Phase III trial in HIV-positive patients with oropharyngeal candidiasis is on track for filing with the U.S. FDA, also in early 2005. "The results from these studies are strongly indicative of the efficacy and safety of our once a day topical formulation of the miconazole extended release, bioadhesive buccal tablet for first line local treatment of oropharyngeal candidiasis," said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. "These excellent results for one of BioAlliance's key technologies are extremely encouraging in terms of the company's future development." Phase III [...]