BioAlliance Pharma SA has announced the extension of its phase II clinical trial with Validive in the US in radio/chemotherapy-induced oral mucositis prevention in patients with head and neck cancer.
Further to approval by the US FDA, BioAlliance Pharma will extend its clinical trial to the US, increasing the number of clinical investigation centers involved in this randomized double blind Phase II trial.
So far almost 50% of planned patients have been enrolled in about 30 European centers. With the upcoming initiation of several centers in the United States, BioAlliance Pharma expects to finalize trial recruitment in early 2014 with results expected the same year.
"Beyond accelerating recruitment, the extension of the trial to the US is also a key factor to reinforce our international panel of scientific experts and clinical investigators around Validive. This will raise awareness and create hands-on experience of the drug of future key prescribers of Validive in major US centers specialized in oncology and radiotherapy", stated Judith Greciet, CEO of BioAlliance Pharma.
Severe oral mucositis is a particularly invalidating pathology occurring in more than 60% of patients treated with radio/chemotherapy for head and neck cancer and has currently no validated curative or preventive treatment. It may induce intense oral pain and eating disability requiring enteral or parenteral nutritional support. Thirty per cent of patients need to be hospitalized as a result and symptoms can force patients to stop treatment for an undefined period thus reducing treatment efficacy.