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Validive® at the MASCC/ISOO International Symposium

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Onxeo S.A. has presented Validive® (clonidine Lauriad®) Phase II clinical trial results at the MASCC/ISOO International Symposium which took place in Copenhagen from June 25 to June 27, 2015 and on this occasion, held a meeting of its Advisory Board to discuss design of the Phase III clinical trial.

The annual MASCC/ISOO 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. Validive® was distinguished to be part of this oncology supportive care forum with an oral presentation of the positive final results of its Phase II clinical trial.

These final data confirm the product's favorable safety profile and efficacy in reducing severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. These positive results provide the basis for a Phase III trial to further evaluate the efficacy of Validive®, which Onxeo plans to initiate by end 2015/early 2016.

This event was therefore the designated opportunity for Onxeo to bring together some members of its international Advisory Board dedicated to oral mucositis and to the associated clinical development program with Validive®.

At this point in the product's development stage, the discussion was focused on the Board's recommendations on the Phase III trial design, especially in terms of indication, dosage, population and clinical endpoints, based on the phase II final results.

"We were very happy to share these positive results with the medical community, and in particular with those who need to provide their patients with a new, attractive therapeutic option to prevent severe oral mucositis, a severe condition induced by chemoradiation therapy for which no preventive treatment is currently available. Clonidine Lauriad represents a very promising product and its mucoadhesive formulation makes it especially well adapted to treat oral mucositis ", comments Pr René-Jean Bensadoun, principal investigator of the Phase II clinical trial.

"The MASCC conference has been a great opportunity for us to meet with our key advisors to discuss further plans for the development of Validive® further. The board has shown again great enthusiasm around Validive® as a potential treatment of severe oral mucositis and we would like to thank them for their support and accurate advice as international experts of Oral Mucositis, regarding our phase III plan. ", added Graham Dixon, CSO Head of R&D of Onxeo.