ORYX Enrols First Patients in a Dose-Escalating Phase I/IIa Pilot Study with Oncolytic Virus ParvOryx to Treat Metastatic Pancreatic Cancer
Munich (Germany): ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today announced that the first patient has been treated in a dose-escalating Phase I/IIa pilot study with ParvOryx, to treat patients with metastatic, inoperable pancreatic cancer. The first patient has completed the treatment and no serious side effects have been reported. ParvOryx is a wild type rat oncolytic parvovirus (H-1PV), which can be repeatedly applied via the intravenous and intratumoral route because of lack of prior immunity in patients.
The trial is an open label pilot study in 7 patients with inoperable pancreatic tumors having at least one hepatic metastasis. The patients receive ParvOryx at three increasing dose levels, partly administered intravenously on four consecutive days, followed by an intrametastatic injection six to thirteen days thereafter. The primary endpoint of the trial is safety, humoral immune response, viral genomes in blood and viral shredding. Secondary endpoints include anti-tumor effects and cellular immune response, plus progression free survival and overall survival.
Dr. Dr. Michael Dahm, CMO of ORYX, commented: “In this new trial, we want to validate the mode of action of ParvOryx in another tumor entity, which is inoperable metastatic pancreatic cancer. We are confident that the positive results of oncolytic virotherapy already shown in our previous trial in glioblastoma patients can, also, be confirmed in this fatal indication. Positive results would strongly support our expectation that ParvOryx holds extraordinary potential to treat a variety of cancers.”
In a previous dose-escalating two-arm Phase I/IIa study in patients with progressive recurrent glioblastoma (GBM, UICC Stage IV), ParvOryx clearly demonstrated safety as primary endpoint in all 18 patients. 14 patients (77,8%) showed an overall survival of at least six months, some of them significantly longer (40,9 months). ParvOryx, which passes the blood brain barrier when applied systemically, induced both strong tumor infiltration patterns and cellular immune responses against glioma and viral proteins (bystander effect) in dose-dependent manner.
The company will deliver a presentation at BIO-Europe Spring 2016 in Stockholm, Sweden, on Tuesday, April 05, 2016, at 16:15 PM in Room E6/7 on level 0 of the Kistamässan Convention Center.
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