NEW YORK – Prestige Biopharma said on Sunday that it will begin a clinical trial in France evaluating its investigational therapy PBP1510 as a treatment for pancreatic cancer patients whose tumors overexpress PAUF.
The French National Agency for the Safety of Medicines and Health Products has given Singapore-based Prestige the go-ahead to begin the Phase I/II trial of the anti-PAUF monoclonal antibody, which will take place at France's Research Institute against Digestive Cancer.
The firm will also conduct the trial in other countries, including in the US, Australia, Belgium, and Korea, contingent on permission from respective regulatory bodies. Korea's Ministry of Food and Drug Safety, or MFDS, is currently reviewing Prestige's application to conduct the trial in Korea, and last year, MFDS, the US Food and Drug Administration, and the European Medicines Agency all granted orphan drug designation to PBP1510.
PBP1510 is designed to target PAUF, or Pancreatic Adenocarcinoma Up-regulated Factor, which plays a role in disease progression. The gene is commonly expressed in pancreatic cancers but has not been the target for any other therapies, making PBP1510 first in class.