Thursday, March 15, 2018
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, today 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.
"We are delighted with the results from the reproduction run, which shows that the proprietary process is scalable and robust so that we can produce our drug substances, routinely," said James Nathanielsz, Propanc Biopharma's Chief Executive Officer. "As a result, the Company requested a scientific advice meeting with the MHRA to update the agency about our progress."
"The Propanc management team continues to remain focused and diligent regarding the advancement of PRP into clinical trials," said Professor Klaus Kutz, Propanc Biopharma's Chief Medical Officer. "Our regulatory and development team are working hard to ensure we have good communication with the MHRA."
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. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company's initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research.
