BioAlliance Pharma, a developer of orphan oncology products and supportive care products, initiated its phase II clinical trial evaluating the efficacy and safety of Validive (clonidine Lauriad) in the U.S. in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer.
The first U.S. investigational sites were initiated in May and are ready to start recruiting patients, while a total of 20 U.S. sites are planned to be initiated in the coming weeks.
The clinical trial is being conducted in 30 centers in four countries: France, Germany, Spain and Hungary.
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 to early 2014 with results in 2014.
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.