MELBOURNE, Australia– Propanc Biopharma, Inc. (OTCQB: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced that pharma grade raw materials were purchased for the manufacture of PRP in preparation for the Phase I First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. Approximately 0.5kg of trypsinogen and 2.4kg of chymtrypsinogen was procured initially, with a second half of the same batch quantities to be purchased towards the middle of this year. The total amount of raw materials purchased is expected to be sufficient for the early-stage clinical development plan for PRP, which is administered by intravenous (I.V.) injection, once weekly. The first FIH study is planned for treatment of up to 30 to 40 patients with advanced solid tumors. This will be followed by up to two 60 patient Phase II studies in patients suffering from pancreatic and ovarian tumors.
The initial pharmaceutical grade raw materials have been purchased from the Company’s preferred supplier, through a collaborative arrangement with an active pharmaceutical ingredient (API) sourcing agent, with specific expertise in the industrial use of enzymes. Through extensive research and development activities with a selected contract manufacturing organization (CMO) and contract research organizations (CRO’s) predominantly in the EU over several years, the Company has now developed a proprietary purification method and manufacturing process to produce PRP in sufficient commercial quantities for scale up and to Good Manufacturing Process (GMP) standard, with the goal of international regulatory approval of PRP, administered by I.V. injection.
“We are entering a significant development phase for PRP, as we advance towards a FIH study for the treatment and prevention of metastatic cancer from solid tumors,” said James Nathanielsz, Propanc’s Chief Executive Officer. “Our intellectually intensive work to produce a pharmaceutical preparation of PRP to GMP standard, administered by I.V. injection, is a world first, and we remain steadfast in our belief that PRP has the potential to be a long-term therapeutic option for patients, where metastatic cancer remains the main cause of patient death, free from the side effects usually associated with standard treatment options. In the context of this current global environment, such approaches are urgently needed.”
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung liver, uterine and skin cancers.
