BioAlliance Pharma SA to enter Phase II clinical trial for clonidine Lauriad and Phase I clinical trial for AMEP

Dec 15 2009

BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces the approval from the French Drug Agency (AFFSSaPS) to enter Phase II clinical trial for clonidine Lauriad^® in radiotherapy and chemotherapy-induced oral mucositis and the approval from Danish and Slovene Agencies to enter Phase I clinical trial for AMEP^TM in invasive melanoma.

Clonidine Lauriad^® uses the innovative muco-adhesive technology validated with Loramyc^® and more recently with acyclovir Lauriad^®. This new product is dedicated to the prevention and the treatment of radiotherapy and chemotherapy-induced oral mucositis in cancer patients. Clonidine Lauriad^® is part of the supportive care pipeline BioAlliance Pharma is building. This product presents the opportunity to satisfy an unmet medical need. Patent application has been filed.

AMEP™, anti-invasive biotherapy, is dedicated to metastatic and invasive melanoma, an advanced skin cancer refractory to most treatments. Its original mechanism of action targets specific receptors involved in tumor growth and in tumor angiogenesis. This project is supported by OSEO (the French state innovation agency) which finances technological breakthrough projects and has been granted €6.4 million to participate in its clinical development.

In both trials, the first patients should be recruited early 2010.

« With fentanyl Lauriad^®, clonidine Lauriad^® and AMEP^TM, BioAlliance Pharma’s Teams have fulfilled our objective to bring these three products into clinical phase in 2009 while using our industrial know-how of Lauriad^® mucoadhesive technology, and confirming significant progress in the development of our new cancer chemical entities”, comments Dominique Costantini, President and CEO of BioAlliance Pharma.