FDA grants Validive® (clonidine Lauriad®) with a Fast Track Designation for the prevention and treatment of oral mucositis induced by anticancer treatments

BioAlliance Pharma SA (Euronext Paris - BIO), an innovative Company dedicated to the development of orphan oncology, announced today that Validive® (clonidine Lauriad®) received a Fast Track designation from the U.S. Food and Drug Administration (FDA) for the prevention and treatment of oral mucositis induced by radiotherapy and/or chemotherapy in cancer patients.

The Fast Track procedure is designed to facilitate interactions with the FDA and optimize the development time and review period for drugs investigated as treatments for serious or life- threatening diseases with a high unmet medical need.

Severe oral mucositis is a highly disabling disease, induced by intensive radiochemotherapy protocols, particularly frequent in patients treated for head and neck cancer. At severe stage, it induces intense oral pain and eating disability, requiring enteral or parenteral nutritional support. Hospitalization is needed in about 30% of patients and symptoms can lead to anticancer treatment breaks or delays, impacting overall chance of success for the treatment. No validated curative or preventive treatment is currently available.

“The FDA’s decision to grant Fast Track Designation to Validive® reflects FDA’s awareness about the seriousness of oral mucositis disease, the strong need for an effective treatment and Validive®’s potential to address this highly disabling disease. This designation is key for Validive® development, it will allow an accelerated review period by the FDA at the time where we are finalizing our large international double blind phase II trial. Last patient is planned to be enrolled in the coming weeks and top line data should be issued in the second half of the year. Validive® is the second most advanced product of our orphan oncology program, which drives the company growth. The achievement of the phase II program is a major step to be achieved soon for one of our key assets”, commented Judith Greciet, CEO of BioAlliance Pharma.

Validive® (clonidine Lauriad®) is a mucoadhesive tablet based on our Lauriad® technology that delivers high concentrations of an anti-inflammatory active principle (clonidine) directly in the oral cavity, the site of irradiation in the treatment of head and neck cancer.