Enrollment for additional phase I trial of HPV-vaccine
ORYX's vaccine in addition to chemotherapy in HPV-associated cancers
ORYX 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.
Previously, VicOryx clearly demonstrated the capability to generate a humoral or cellular immune response. The primary endpoint of the Phase I/IIa study was achieved in all 26 patients, who received VicOryx after the completion of chemotherapy. In the study, 15 patients were amenable to an analysis of a tumor response, of those 10 (67%) showed stable disease and 5 (33%) suffered from tumor progression. No patient showed a partial response (PR).
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