BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to specialty and orphan pharma products in oncology and supportive care, today announced the extension of its ongoing clonidine Lauriad™ phase II clinical trial in chemoradiation therapy induced oral mucositis in patients with head and neck cancer to Germany and Spain. 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™.
“The orphan drug designation will qualify clonidine Lauriad™ for our “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”, comments Judith Greciet, Chief Operating Officer, Operations and R&D of BioAlliance Pharma.
BioAlliance Pharma second Business Unit “Specialty Pharma” includes both registered Loramyc® (oropharyngeal candidiasis in immunocompromised patients) and Setofilm® (chemo- and radiotherapy-induced nausea and vomiting), Sitavir® (recurrent herpes labialis), which is in registration phase, as well as other earlier projects which will contribute to generating revenues through partnering.