BioAlliance Pharma has commenced a Phase II clinical trial of Validive (clonidine Lauriad) to assess the its efficacy and safety profile in treating chemoradiation therapy-induced oral mucositis in head and neck cancer patients.
Following IND approval by the US Food and Drug Administration (FDA), the investigation will be carried out at about 20 sites in the US over the next few weeks.
The first investigational sites are ready to start enrolling patients with chemoradiation therapy-induced oral mucositis with head and neck cancer for the trial.
Expected to be finalised in late 2013 or early 2014 with results in 2014, the clinical trial is also being carried out at 30 centres in four European countries, including France, Germany, Spain and Hungary.
In Europe, the study has enrolled more than 60% of the planned patients to date, and the recruitment process is expected to increase with the site extension in US.
BioAlliance Pharma CEO Judith Greciet said Validive is a drug that meets a strong medical need in a pathology with no existing preventive validated treatment.
"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," Greciet said.
"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."
Currently, there is no validated curative or preventive treatment for severe oral mucositis, which affects over 60% of patients treated with radio / chemotherapy for head and neck cancer.