BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today announced the completion of enrollment in the Phase II clinical trial with Validive® (clonidine Lauriad®) in the prevention and treatment of severe oral mucositis induced by radiotherapy and/or chemotherapy in head and neck cancer patients.
This large and robust randomized, double-blind, placebo-controlled phase II trial, planned to include 183 patients, has been conducted in more than thirty centers in Europe and in the United States. The trial is assessing the efficacy and safety of Validive® 50 µg and 100 µg versus placebo in prevention of severe oral mucositis, a highly disabling condition with currently no approved treatment. BioAlliance Pharma expects to announce preliminary results Q4 2014.
Moreover, BioAlliance Pharma was selected to present preclinical data on Validive® at the 50th ASCO Meeting that will take place in Chicago from 31 May to 3 June, 2014. Two publications were accepted by the scientific committee of this internationally recognized scientific association.
« The recruitment phase being completed, we are now eager to enter the upcoming step: the preliminary results, expected Q4 2014, which will be the basis for the development strategy to lead the product to registration. With the “Fast track” designation granted by the FDA earlier this year, and the “orphan status” obtained for Europe, Validive® will benefit from major advantages to optimize review periods from both agencies ”, comments Judith Greciet, CEO of BioAlliance Pharma.
“To be selected by the ASCO scientific committee to present preclinical data reflects the interest and the quality of our data, and is a great honour and pride for our teams. Validive® is the second leading program of our “orphan oncology products” portfolio. All operations are now in place to continue the development of this strong asset for the Company, whose sales potential could reach €200 to €400 million”.