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BIOALLIANCE PHARMA

Anti-Fungal Agent Greenlighted

The clinical trial program for European registration is complete and today we are proud to have been given the US go-ahead for phase III.”1 Gilles Avenard and Dominique Costantini are the co-founders of Bioalliance Pharma, a French biopharmaceutical company specialized in the development and commercialization of innovative therapies, but also in drug resistance in serious diseases like cancer and AIDS. The two medical doctors created this company in 1997 based on their alliances with the academic world (CNRS, INSERM, and various universities) and a venture-capital financing plan. The company went public in December 2005, with a secure €30 million invested. Avenard is confident: “Today, 50 people are working on a dozen projects. The most advanced is miconazole Lauriad which will be launched in France early 2007 and then submitted to commercialization at the European level. The US Food and Drug Administration has just approved their submission for an IND (authorization to undertake clinical research on a new drug in the US). Bioalliance will therefore launch its pivotal phase III trial in the US, which will be the last step in clinical testing before commercialization of its lead product.

“The product is an anti-fungal agent, miconazole Lauriad, a drug for first-line treatment of fungal infections caused by the Candida group of fungi in immunodepressed patients suffering from cancer, infected with HIV, transplant patients, or diabetics,” explains Avenard. “The innovation resides in bioadhesive technology that achieves a sustained release of an oral tablet, thereby maintaining a constant anti-fungal concentration in the saliva. By increasing contact time and concentration of the product, we are able to limit the dose to only one per day. We also avoid using a systemic drug which often leads to resistance and/or drug interaction.”

Commercialization of the drug could allow the company to independently finance its operations while awaiting the completion of two other projects already in clinical trials: acyclovir Lauriad for the treatment of oral herpes (end of phase I), and the nanotechnology Doxorubicin-Transdrug for primitive cancer of the liver (in phase I/II).

 

Camille Lamotte

 

 

Notes :

1. In clinical trials on humans, phase III trials test for the therapeutic effectiveness of the drug. Phase I trials test for toxicity while phase II trials test for the optimal dose.

Contacts :

Gilles Avenard
gilles.avenard@bioalliancepharma.com


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