Therapy Areas: Respiratory
Propanc Biopharma Purchases Pharma Grade Raw Materials for PRP Manufacture in Preparation for Phase I First-In-Human Study
2 May 2022 - - Australia-based biopharmaceutical company Propanc Biopharma, Inc. (OTCQB: PPCB) has purchased pharma grade raw materials for the manufacture of PRP in preparation for the Phase I First-In-Human study in advanced cancer patients suffering from solid tumors, the company said.

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 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 sourcing agent, with specific expertise in the industrial use of enzymes.

Through extensive research and development activities with a selected contract manufacturing organization 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 standard, with the goal of international regulatory approval of PRP, administered by I.V. injection.

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.

Propanc Biopharma is developing a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian and colorectal cancers.

The company's novel proenzyme therapy is based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas.

These pancreatic enzymes could represent the body's primary defense against cancer.