Policy & Regulation
Propanc Biopharma Completes Development of Bio-analytical Assay Method to Quantify PRP's Active Ingredients in Preparation for First-In-Human Study
12 August 2019 - - Australia-based biopharmaceutical company Propanc Biopharma, Inc. (OTC: PPCB) has developed a method to quantify the active ingredients of Propanc's lead product candidate, PRP, in preparation for the company's First-In-Human study, planned for early 2020, the company said.

The work was conducted by Propanc's research partner based in Berlin, Germany, who has extensive experience in the development of functional assays for unique bio-therapeutics.

This bioanalytical method development and validation plays a significant role in evaluation and interpretation of the systemic absorption of PRP in clinical studies including its distribution, and clinical effects throughout the body.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen, administered by intravenous injection. The naturally derived proenzymes are very large and complex protein structures that can be broken down into different fragments that can be difficult to separate and analyze from human serum.

The remarkable achievement to identify and develop a suitable method to measure four key analytes from PRP, the two proenzymes, trypsinogen and chymotrypsinogen, as well as the activated enzymes, trypsin and chymotrypsin, is particularly significant due to the close structural similarity of each protein structure.

By using a highly sensitive detection system like Liquid Chromatography/Mass Spectrometry, a suitable method was developed that could separate, identify and quantify all four analytes.

Moreover, a strong correlation between the concentration and signal intensity was established with a R2 = 0.9996, where 1.0000 represents a linear, straight line, indicating a direct correlation between the two variables measured.

This is especially important when measuring the concentration of the analytes within a certain range over time, providing valuable information regarding dosing and the clinical effects of a drug, like PRP, when administered to patients. Lower limits of quantification and detection were also established.

The development of the bioanalytical assay is also an important step for the clinical development of PRP, as Propanc evaluates sites to conduct the FIH study in advanced cancer patients, such as the Peter Mac Center, Australia's largest cancer hospital, which has significant experience in early stage clinical development.

Propanc is evaluating Australia as a potential destination where it may commence the Phase Ib clinical trial because of its research and development tax incentives, as well as a simplified regulatory environment.

As part of such incentives, eligible companies conducting clinical trials in Australia may receive up to 43.5% "cash-back" benefit in the form of a refund of their qualified research and development costs and expenses.

Propanc Biopharma, Inc. 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.
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