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Onxeo to Present Trial Results

Onxeo S.A.’s Validive®’s (clonidine Lauriad®) phase II clinical trial results have been accepted for an oral presentation at the MASCC/ISOO International Symposium scheduled for June 25-27 in Copenhagen.

The company specializes in the development of orphan oncology drugs.

The MASCC/ISOO Annual meeting focuses on supportive care for cancer patients and especially on therapeutic options to minimize symptoms and complications associated with cancer, as well as therapy-induced side effects


Onxeo reported positive preliminary top-line results in October 2014 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 good safety results. Based on these data and Onxeo’s Board of experts’ opinion, the company intends to initiate a Phase III trial to confirm the product’s efficacy and safety profile by the end of 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,” says Judith Greciet, CEO of Onxeo. “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.”

Severe oral mucositis is a particularly invalidating pathology occurring in more than 60 percent 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.