The expansion of the trial (currently ongoing in France) to two new countries will raise the total number of centers to over 40 and will help accelerate patient recruitment.
Based on the incidence of chemoradiation therapy induced oral mucositis in this population, BioAlliance Pharma plans to submit an application dossier to the European and US agencies in Q2 2011 to obtain an orphan drug designation for clonidine Lauriad.
BioAlliance Pharma Operations and R&D COO Judith Greciet said the orphan drug designation will qualify clonidine Lauriad for ‘Orphan Oncology’ Business Unit, which features breakthrough products for severe and rare cancers.
"In addition to clonidine Lauriad, this unit covers various projects including, at clinical stage, Livatag (advanced hepatocellular carcinoma) in phase II and the AMEP biotherapy (invasive metastatic melanoma) in phase I," Greciet said.