Oral presentation of Phase II trial results of Validive® at the MASCC/ISOO International Symposium
Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that Validive® (clonidine Lauriad®) phase II clinical trial results have been accepted for an oral presentation at the MASCC/ISOO International Symposium taking place in Copenhagen from June 25 to June 27, 2015.
The MASCC/ISOO Annual meeting is dedicated to supportive care in cancer and particularly to therapeutic options to minimize symptoms and complications associated with cancer as well as therapy-induced side effects. Its international and multidisciplinary approach dedicated to research and education positions MASCC/ISOO as a reference organization in this growing field.
Late October 2014, Onxeo reported positive preliminary top-line results of the large international Phase II clinical trial with Validive® in the prevention of oral mucositis in patients undergoing head and neck cancer treatment. The study showed a reduction in the incidence of severe oral mucositis with a very good safety. Based on these data and upon Onxeo’s Board of experts opinion, the company intends to initiate a Phase III trial to confirm product’s efficacy and safety profile end 2015.
“After a poster presentation of its Phase II results at a major event in the field of oncology, the ASCO 2015 annual meeting, Validive® is now distinguished by the oncology supportive Care international specialists forum. Both selections highlight the quality of the trial and the data obtained as well as the interest of the product in the prevention of severe oral mucositis. These distinctions reinforce our convinction that Validive® is a key asset of our pipeline ”, comments Judith Greciet, CEO of Onxeo.
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.