ActoGeniX gets nod for oral mucosits trial
ActoGeniX, a German developmental-stage biopharmaceutical company, has received US Food and Drug Administration approval for its Investigational New Drug application for AG013, a novel therapeutic product for the treatment of oral mucositis in cancer patients.
The firm will now initiate a Phase Ib study evaluating the safety and tolerability of the product, as well as efficacy data. The placebo-controlled, single blinded, dose-escalation study is expected to be completed during the first half of 2010.
Chief medical officer Bernard Couli said: "with the advancement into clinical development of AG013, our second lead product, ActoGeniX is well on its way to effectively build a significant clinical-stage product pipeline. Moreover, AG013 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumors or head/neck cancers."
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