15 March 2018 | News
The Company's initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020
Propanc Biopharma Inc., a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, announced the successful reproduction run of the manufacturing process for the Company's two drug substances trypsinogen and chymotrypsinogen.
The successful reproduction run demonstrates scalability of Propanc's proprietary manufacturing process to enable routine production of the two active substances for the Company's lead product candidate, PRP. The process was developed in collaboration with a European Contract Manufacturing Organization (CMO) experienced in the production of biopharmaceuticals.
As a result of the successful reproduction run, a scientific advice meeting was requested with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to inform them of the results from recent manufacturing activities and confirm requirements for the next stage of GMP manufacture for PRP.
Given the unique potential of these active biological drug substances, management continues to engage in proactive communication with the regulators to advance the product candidate towards clinical and market approval.
PRP is a proposed solution for once-daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards a First-In-Human study, PRP aims to prevent tumor recurrence and metastasis from solid tumors.