BioWorld International Correspondent
PARIS - BioAlliance Pharma SA plans to file its miconazole Lauriad for regulatory approval in Europe early this year as a first-line local treatment for oropharyngeal candidiasis, an oral fungus found in immuno-compromised patients suffering from diseases such as cancer, HIV and diabetes.
At the same time, the Paris-based company is to file an investigational new drug application with the FDA for the conduct of a pivotal Phase III trial in the U.S. on HIV-positive patients suffering from oropharyngeal candidiasis.
Those decisions follow the announcement of positive preliminary results from a confirmatory Phase III trial in Europe of BioAlliance's once-a-day topical formulation of miconazole as a 50-mg, extended-release mucosal bioadhesive tablet. That trial tested the use of miconazole Lauriad for the local treatment of oropharyngeal candidiasis in head and neck cancer patients following radiotherapy. The tablet used in the trial contained 10 times less active ingredient than the same drug when applied as a topical gel.
An earlier Phase III trial in HIV-positive patients, completed in August 2003, yielded positive results, recording a 94.7 percent clinical response rate. Those two sets of results will form the basis for the regulatory filing of micanozole Lauriad in Europe. BioAlliance plans to file in the U.S. in 2007.
Commenting on the clinical trial outcome, the company's president and CEO, Dominique Costantini, stressed that "these excellent results for one of BioAlliance's key technologies are extremely encouraging in terms of the company's future development."
The company is developing therapeutics and predictive assays in the field of drug resistance using proprietary drug delivery systems based on adhesive and nanoparticle technology, and it is focusing on cancer and infectious diseases, especially HIV, HBV and hepatocellular carcinoma. Its nanoparticle technology uses the polymer poly-iso-hexyl-cyanoacrylate to produce cancer drugs comprising drug-loaded nanoparticles that are delivered direct into the cancer cell.
BioAlliance has another drug candidate in clinical development, doxorubicin Transdrug. A Phase I/II trial of that product is under way at seven sites in France for the treatment of hepatocellular carcinoma. Last November, the European Medicines Evaluation Agency granted doxorubicin Transdrug orphan drug status in that indication, and BioAlliance has filed a similar application with the FDA.
BioAlliance in September completed a Series C financing in which it raised €12 million (US$16 million) from a group of European venture capital companies, bringing to €18 million the total funding it has raised since its creation in 1997.