Singapore-based biopharmaceutical firm Prestige BioPharma Ltd. recently announced that it has received approval from the French National Agency for the Safety of Medicines and Health Products for a Phase 1/2a clinical trial of PBP1510, its pancreatic cancer treatment.

The clinical trial includes patients with pancreatic cancer having overexpression of a gene termed as PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), found in most pancreatic cancers, and will be conducted at the IRCAD (Research Institute against Digestive Cancer) in Strasbourg, France. Prestige Biologics, a PBP affiliate, will provide medications for the clinical trial.

The firm is also gearing up for the trial in other economies like Australia, the United States, and Belgium. PBP's application to conduct this clinical research in Korea is now being reviewed by Korea's Ministry of Food and Drug Safety (MFDS).

For the unaware, pancreatic cancer is fatal cancer that starts in the endocrine or exocrine cells of the pancreas and is believed to be triggered by smoking, poor diet, and genetic aspects. It is responsible for severe mortality and morbidity, with a 9% survival rate at five years in the United States.

Lack of efficient treatment modalities and speedy growth of pancreatic cancer can be partially explicated by PAUF, which plays a crucial part in the development of the disease. However, currently, there is no specific molecular therapy to address PAUF.

The anti-PAUF antibody PBP1510 from Prestige BioPharma is expected to offer considerable benefit to all patients with PAUF-positive pancreatic cancer.

Commenting on the development, Lisa S. Park, CEO at Prestige BioPharma, mentioned the company will fast-track the progression of PBP1510 to offer improved treatment for pancreatic cancer, a complex indication to treat with a low response to treatments available at present.

PBP1510 received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS) the previous year.

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