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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

“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.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.