BioAlliance Pharma SA (Euronext Paris – BIO), an innovative company dedicated to the development of orphan oncology products and to supportive care products, held the first meeting of its international Advisory Board dedicated to oral mucositis and to the associated clinical development program with Validive® (clonidine Lauriad®).
This multidisciplinary Advisory Board is composed of internationally recognized European and American experts, in the fields of oral mucositis and oral medicine, oncology and radiotherapy: Drs Stephen Sonis (Boston, Massachusetts), Paolo Bossi (Milano, Italy), Joel Epstein (LA, California), Jorge Giralt Lopez del Segredo (Barcelona, Spain) and Michael Henke (Freiburg, Germany). Its purpose is to provide advice and input on development strategy and medical positioning of Validive® in oral mucositis.
Validive® is currently being developed for the prevention and treatment of chemoradiation therapy-induced oral mucositis in patients with head and neck cancer. The Phase 2 international, double blind, placebo controlled study being conducted in Europe and in the US has enrolled nearly 75% of planned patients. Recruitment should be completed early in 2014 with results and analyses completed later in the year expected to represent a major step towards the validation of Validive®. The Advisory Board will assist BioAlliance Pharma with Validive®’s development strategy and has started assessing the most relevant strategic path from ongoing Phase II to registration.
“Validive®’s biological activities are consistent with the interruption of pathways known to be important in the development of mucositis. Coupled with its unique formulation, Validive® could become an attractive option for the prevention of oral mucositis, a severe treatment complication for which no preventive treatment is currently available,” comments Stephen Sonis.
“Moreover, this panel of worldwide scientific and medical experts in oncology treatment-induced oral mucositis will help us design the future trials with Validive®, a key asset in our Orphan Oncology portfolio, to meet patients’ needs and help us to maximize the potential of Validive® in this disabling disease,” adds Pierre Attali, BioAlliance Pharma’s Chief Operating Officer in charge of strategy and medical affairs.
About Severe Oral Mucositis
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 percent 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.