Munich (Germany), September 15, 2015: ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today announced that first patients have been treated in an additional Phase I clinical trial with VicOryx, a therapeutic vaccine to treat p16INK4a overexpressing Human Papilloma Virus (HPV) positive cancer patients, in combination with standard cisplatin-based chemotherapy. The patients have undergone the first weeks of treatment and no serious side effects have been reported.
The trial is an open label study in 10 patients with HPV-associated anogenital (cervical, vulvar, vaginal, penile, and anal) tumor diseases or HPV-associated head and neck cancer who are scheduled to receive a cisplatin-based chemotherapy. The patients receive VicOryx, a synthetic p16INK4a peptide, combined with the adjuvant Montanide(R) ISA-51 VG subcutaneously plus a cisplatin based chemotherapy once a week for four weeks followed by a four week pause. Each patient will be treated in three cycles over six months or until tumor progression occurs. The primary endpoint of the trial is an immune response against the p16_37-83 peptide. Secondary endpoints include tumor response rates, progression free survival and overall survival, plus safety of the therapeutic vaccine administration.
Read more: http://www.dgap.de/dgap/News/corporate/oryx-enrols-first-patients-additional-phase-trial-with-therapeutic-vaccine-vicoryx-treat-hpvassociated-cancers-combination-with-standard-chemotherapy/?newsID=898239