The Conversation (0)
Propanc Biopharma provided an update on the starting stages of their First-In-Human study towards the full-scale manufacture of the investigational medicinal product PRP.
Propanc Biopharma (OTCQB:PPCB) provided an update on the starting stages of their First-In-Human (FIH) towards the full-scale manufacture of the investigational medicinal (IMP) product PRP.
As quoted in the press release:
The full scale manufacture of PRP is a key step in order to submit the Company’s first clinical trial application, expected in early 2018.
“We are very pleased with the progress of the purification and characterization of the two key active components for PRP, trypsinogen and chymotrypsinogen, and we’re now moving into the Good Manufacturing Practice (GMP) phase of the manufacturing process, to ensure the IMP meets the strict guidelines for pharmaceutical use in humans,” said James Nathanielsz, Propanc’s Chief Executive Officer. “As a result of our progress, we are now commencing preparation of the clinical trial application (CTA) for our FIH study with PRP, which includes the investigational medicinal product dossier (IMPD), investigator’s brochure (IB) and study protocol. The study will be led by Professor Klaus Kutz, our Chief Medical Officer.”
Click here to read the full press release.
Source: www.marketwired.com
