BioWorld International Correspondent
PARIS - BioAlliance Pharma SA reported that its Phase III trial of miconazole Lauriad, its formulation of miconazole as a once-a-day, extended-release mucosal bioadhesive tablet, attained its primary endpoint.
The trial tested Lauriad in oropharyngeal candidiasis in patients who had undergone radiotherapy for head and neck cancer. Oropharyngeal candidiasis is an oral fungus commonly found in immuno-compromised patients suffering from diseases such as cancer, HIV and diabetes.
The trial established that 50-mg Lauriad was as effective as miconazole applied as a 500-mg topical gel, despite containing 10 times less active ingredient. Paris-based BioAlliance considers that its formulation offers greater flexibility of use and thus will result in improved compliance by patients.
The trial was carried out on 306 patients at 36 sites in France and North Africa. Not only had all the subjects received radiotherapy, but two-thirds also had received some form of chemotherapy for their cancer. The primary endpoint was to establish equal efficacy for 50-mg Lauriad administered once a day for two weeks in comparison with 500-mg miconazole oral gel administered in four equal doses per day for the same period. Secondary endpoints were to compare other efficacy criteria after seven days and again after 14 days, as well as the safety profile.
BioAlliance Pharma already has filed miconazole Lauriad for regulatory approval in Europe as a first-line local treatment for oropharyngeal candidiasis on the strength of the preliminary results of the trial. It also has filed an investigational new drug application with the FDA for the conduct of a Phase III trial in the U.S. on HIV-positive patients suffering from oropharyngeal candidiasis. The company hopes to file the product in the U.S. in 2007.
BioAlliance's nanoparticle technology uses the polymer PIHCA (poly-iso-hexyl-cyanoacrylate) to produce cancer drugs comprising drug-loaded nanoparticles that are delivered directly into the cancer cell.