BioAlliance Pharma SA (Euronext Paris – BIO), a Company dedicated to the development of orphan oncology products and supportive care products, announces the initiation of its Phase II clinical trial evaluating the efficacy and safety of Validive® (clonidine Lauriad®) in the United States in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer, as scheduled in the advancement calendar of the project.
Further to IND approval by the United States Food and Drug Administration (FDA), the first investigational sites have been initiated in May in the U.S. and are ready to start recruiting patients. About twenty sites are planned to be initiated in the U.S. in the coming weeks.
“This extension was set up thanks to our teams’ involvement and to a marked interest of clinicians from major U.S. centers specialized in oncology and radiotherapy for Validive®, a drug that meets a strong medical need in a pathology with currently no preventive validated treatment,” declares Judith Greciet, CEO of BioAlliance Pharma.
The clinical trial is also being conducted in Europe in about thirty centers in 4 countries: France, Germany, Spain and more recently Hungary.
So far, more than 60% of planned patients have been enrolled in Europe and the U.S. extension is planned to help accelerate the recruitment. The trial is expected to be finalized in late 2013/early 2014 with results in 2014.
“Thanks to the initiation of additional sites, especially in the United States, the acceleration of the Validive® clinical trial enables the expectation of results as soon as next year. This is a crucial step to firmly validate the efficacy of Validive® in the severe oral mucositis, strongly reinforcing the value of this leading drug of our orphan oncology portfolio,” adds Judith Greciet.
Severe oral mucositis occurs in more than 60% of patients treated with radio/chemotherapy for head and neck cancer, and currently has no validated curative or preventive treatment. It may induce intense oral pain and eating disability leading to hospitalization and enteral or parenteral nutritional support. The disease also frequently requires stopping, sometimes for a prolonged period, the cancer treatment protocol, thus strongly impacting treatment efficacy for the patient.