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OnxeoÂ’s Validive drug candidate ready for Phase III

Onxeo released the final results of Validive’s Phase II clinical trial, which confirmed the preliminary findings published last October. Taken daily over the course of the chemoradiotherapy treatment (8 weeks), Validive (clonidine Lauriad) was able to reduce the occurrence of Severe Oral Mucositis, while reducing chemoradiotherapy-related adverse events (nausea, dysphagia). This proof of concept establishes the basis of the Phase III study, expected to start at the end of 2015, to confirm these results in a larger population of Head and Neck cancer patients. Onxeo develops innovative products to address pathologies of high unmet medical needs: Validive, now Phase III ready, Livatag in Phase III, to fight primary liver cancer, and belinostat, a pan-HDAC inhibitor, whose good safety and tolerance profile supports its use in multiple cancer indications as a monotherapy or combination therapy. We maintain our valuation (including net cash) at €10.03/share.