Enrollment for additional phase I trial of HPV-vaccine
ORYX's vaccine in addition to chemotherapy in HPV-associated cancers
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).
Most read news
Organizations
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.