KUALA LUMPUR: Prestige BioPharma Limited (PBP) announced that French National Agency for the Safety of Medicines and Health Products has approved a Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510, for pancreatic cancer treatment.
The trial will be conducted in the Research Institute against Digestive Cancer (IRCAD) based in Strasbourg, France, in pancreatic cancer patients who have an overexpression of a gene called Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancers.
According to a statement, PBP’s affiliate, Prestige Biologics will be providing drugs for the trial.
Specialising in the development of antibody therapeutics, PBP is also in the process of preparing for the conduct of this trial in other countries such as the US, Australia and Belgium.
In addition, Korea’s Ministry of Food and Drug Safety (MFDS) is currently reviewing PBP’s application for conduct of this clinical trial in Korea, as well.
“We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in France. PBP will accelerate the development of PBP1510 to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments,” said Prestige BioPharma Chief Executive Officer, Lisa S. Park.
Pancreatic cancer is a highly aggressive malignancy originating in the exocrine or endocrine pancreatic cells suspected to be caused by poor diet, smoking, and genetic factors.
Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by PAUF and it plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists.
Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit in all patients affected by PAUF-positive pancreatic cancer.
More details at www.prestigebiopharma.com. – Bernama