Prestige Biopharma’s First Class Pancreatic Cancer Treatment PBP1510 Receives Clinical Trial Approval in France – .

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Prestige Biopharma’s First Class Pancreatic Cancer Treatment PBP1510 Receives Clinical Trial Approval in France – .


SINGAPORE-(COMMERCIAL THREAD) –Prestige BioPharma Limited (PBP), which specializes in the development of therapeutic antibodies, announced that the National Medicines Safety Agency (ANSM) has approved a Phase 1 / 2a clinical trial of its anti-PAUF monoclonal antibody first-in-class, PBP1510, for the treatment of pancreatic cancer.

The clinical trial will be conducted at the Institute for Research Against Digestive Cancer (IRCAD) based in Strasbourg, France, in patients with pancreatic cancer who have overexpression of a gene called Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) present in the majority of pancreatic cancers. PBP’s subsidiary, Prestige Biologics, will supply the drugs for the clinical trial.

PBP is also preparing to conduct this trial in other countries such as the United States, Australia and Belgium. The Korean Ministry of Food and Pharmaceutical Safety (MFDS) is currently reviewing the application for PBP to conduct this clinical trial in Korea as well.

Pancreatic cancer is a very aggressive malignant tumor arising from pancreatic exocrine or endocrine cells believed to be caused by poor diet, smoking, and genetic factors. It contributes to high morbidity and mortality with a 5-year survival rate of 9% in the United States. Currently, the only curative options are limited to surgical resection combined with adjuvant chemotherapy. However, only 10 to 15% of patients are candidates because the diagnosis occurs at advanced or metastatic stages that cannot be operated on by surgery. The limited efficacy of treatment modalities and the rapid progression of pancreatic cancer may be partly explained by PAUF and it plays an important role in the progression of the disease, but there is currently no targeted molecular therapy against PAUF. NOT. Prestige BioPharma’s anti-PAUF PBP1510 antibody is expected to provide significant benefit to all patients with PAUF-positive pancreatic cancer.

The European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Korean MFDS granted orphan drug designation (ODD) to PBP1510 last year. The ODD is granted to investigational drugs for the safe and effective treatment of rare diseases with unmet medical need that affect very few people but cause great suffering. This designation provides companies with certain benefits and incentives, including clinical protocol support, differentiated assessment procedures for health technology assessments in certain countries, and, if approved, marketability in the EU for a period of time. 10 years, in the United States for 7 years.

Lisa S. Park, CEO of Prestige BioPharma, commented: “We are very pleased to initiate the Phase 1 / 2a clinical trial of PBP1510 in France” and “PBP will accelerate the development of PBP1510 to provide better treatment for pancreatic cancer, an extremely difficult indication to treat with poor response to available treatments ”.

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