Propanc Biopharma Initiates Development of Bio-Analytical Assay in Preparation for Human Trials
MELBOURNE, Australia, March 25, 2019 /PRNewswire/ -- Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, announced today that it has initiated development of a bio-analytical assay intended to quantify the active ingredients of the company's lead product candidate, PRP, in preparation for human trials, planned for later this year. The work will be conducted by a specialist Contract Research Organization with extensive knowledge in the development of functional assays for different bio-therapeutics. PRP is a solution of two proenzymes, trypsinogen and chymotrypsinogen, administered by I.V. injection.
"We are keen to undertake this important work, as the quantification of PRP in human serum will provide invaluable information that links the biodistribution of the two proenzymes, as it exerts its potent anti-cancer and anti-tumor effects, to the efficacy and safety of our therapy on patients at different dosing levels," said Dr. Julian Kenyon, Propanc's Chief Scientific Officer. "Initially we will carry out a feasibility study to quantify the two proenzymes trypsinogen and chymotrypsinogen, but in addition, the enzymes which become activated at the tumor site, trypsin and chymotrypsin. It is the activated enzymes which exert their effects on the cancer cells, by turning off important protein markers responsible for tumorigenicity and malignancy, so that the cancer cells die naturally. Measuring all four analytes will provide an important link to the action of PRP and its effects on cancer patients."
Development of the bio-analytical assay will be an important step towards the clinical development of PRP, as Propanc considers the possible sites to conduct a First-In-Human study in advanced cancer patients, possibly in Europe, specifically the UK, or at a prominent cancer hospital in Australia, with significant experience in early stage clinical development. Attractive R&D tax incentive benefits could be gained by undertaking the trial in Australia, as well as utilizing world-class facilities dedicated to treating and caring for people with cancer. Propanc will investigate selected clinical trial sites more thoroughly as it commences preparation of a clinical trial application for PRP.
About Propanc Biopharma, Inc.
Propanc Biopharma, Inc. (the "Company") 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. For more information, please visit www.propanc.com.
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.
To view the Company's "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: http://www.propanc.com/news-media/video
All statements other than statements of historical facts contained in this press release are "forward-looking statements," which may often, but not always, be identified by the use of such words as "may," "might," "will," "will likely result," "would," "should," "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "continue," "target" or the negative of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. These factors include uncertainties as to the Company's ability to continue as a going concern absent new debt or equity financings; the Company's current reliance on substantial debt financing that it is unable to repay in cash; the Company's ability to successfully remediate material weaknesses in its internal controls; the Company's ability to reach research and development milestones as planned and within proposed budgets; the Company's ability to control costs; the Company's ability to obtain adequate new financing on reasonable terms; the Company's ability to successfully initiate and complete clinical trials and its ability to successful develop PRP, its lead product candidate; the Company's ability to obtain and maintain patent protection; the Company's ability to recruit employees and directors with accounting and finance expertise; the Company's dependence on third parties for services; the Company's dependence on key executives; the impact of government regulations, including FDA regulations; the impact of any future litigation; the availability of capital; changes in economic conditions, competition; and other risks, including, but not limited to, those described in the Company's Registration Statement on Form S-1, filed with the U.S. Securities and Exchange Commission (the "SEC") on February 25, 2019, and in the Company's other filings and submissions with the SEC. These forward-looking statements speak only as of the date hereof and the Company disclaims any obligations to update these statements except as may be required by law.
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SOURCE Propanc Biopharma, Inc.