ORYX Successfully Completes Phase I/IIa Trial to Treat HPV-Associated Cancers

11-Mar-2015 - Germany

ORYX announced the successful completion of a Phase I/IIa trial of the therapeutic vaccine VicOryx to treat p16INK4a-overexpressing HPV- (Human Papilloma Virus-) positive cancer patients in an open label, single center trial that included 26 patients. Inclusion criteria for the trial were a history of advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancers with diffuse expression of p16INK4a in the tumor, after standard therapy. After an initial interim safety assessment (10 patients), the primary endpoint was the induction of a cellular and/or humoral immune response against the therapeutic vaccine. Secondary endpoints were safety of immunization with VicOryx and tumor response according to RECIST. The vaccine was safe and induced humoral and cellular immune responses. Full data from the trial will be presented at upcoming scientific conferences.

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