Munich (Germany): 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® 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.
Dr. Dr. Michael Dahm, CMO of ORYX, stated: “In this new study, we want to evaluate whether the vaccination with VicOryx during a cisplatin-based chemotherapy in patients with HPV-associated tumor diseases confirms the results of the previous trial setting. We are confident this current Phase I trial will provide further positive insight to the benefits of VicOryx in a combination setting.”
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).
The company will deliver a presentation at BioPharm America 2015, Boston, on Wednesday, September 16, 2015, at 12:15 PM in Room Wellesley, Level 3, of Boston Marriott Copley Place.
ORYX is a privately held Munich based biotech company. ORYX develops three highly innovative drug candidates for the treatment of cancer, originating from leading research institutions like the German Cancer Research Center (DKFZ) and the University of Heidelberg. The ORYX clinical development portfolio consists of an oncolytic virus and two therapeutic cancer vaccines. ORYX holds exclusive, world-wide licenses for all its development projects. For more information please visit: www.oryx-medicine.com
For further information, please contact:
Dr. Bernard Huber
Chief Executive Officer
ORYX GmbH & Co. KG
Katja Arnold (CIRO)
Executive Director MC Services AG
Dr. Dr. Sven Rohmann
Phone: +49-8106-21 311-0