BioAlliance Pharma SA, a company dedicated to the development of orphan oncology products and supportive care products, has started 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 US and are ready to start recruiting patients. Around 20 sites are planned to be initiated in the US in the coming weeks.

“This extension was set up thanks to our teams’ involvement and to a marked interest of clinicians from major US centres 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 30 centres in four countries: France, Germany, Spain and more recently Hungary.

So far, more than 60 per cent of planned patients have been enrolled in Europe and the US 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 per cent 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.

BioAlliance Pharma conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.