Propanc Biopharma provided an update on the development of the GMP-compliant investigational medicinal product (IMP) manufacture of PRP for First-In-Human studies. PRP is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen.
Both proenzymes have been successfully isolated from natural sources to a defined quality and will be purified further to GMP standards to obtain the final IMP. The isolation processes for both proenzymes have been established and scaled up to commercial size quantities. These freeze dried isolates will serve as starting materials for the Good Manufacturing Practice (GMP) manufacturing processes, which are currently under development for both proenzymes by the Company’s manufacturing partner, Q Biologicals, in Ghent, Belgium.
In order to define the optimal purification process, the starting materials were characterized for identity and impurities in the laboratories of Professor Buchner, Chair of Biotechnology, from the Technical University of Munich. Furthermore, analytical methods to initially determine and then control the quality of the starting materials are nearly fully established and specifications defined to ensure a consistent quality of IMP.
“PRP is a unique combination of naturally derived ingredients, which we have been able to source from quality suppliers and have begun the process of improving the quality of the materials to ensure suitability for human use,” said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. “We have been working with our development team and research partners from around the world. We have made exciting progress and are working with high calibre scientists, such as Professor Buchner, to ensure our purification process is fully developed and the process scaled up, so it can be transferred to the GMP suite where the IMP for human use will be produced. These methods and test results will be included in an Investigational Medicinal Product Dossier (IMPD) later this year, which is an essential part of a planned clinical trial application for First-In-Human studies for PRP.”
Currently progressing towards First-In-Human studies, 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 a combined market segment of $14 Billion predicted in 2020, by GBI Research.