Initial Discussion Held with Clinical Investigator at Australia’s Biggest Cancer Hospital
MELBOURNE, Australia--(BUSINESS WIRE)-- Propanc Biopharma, Inc. (OTC Pink: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced that the Company will target the Peter Mac Cancer Center in Melbourne, Australia, as the site for the First-In-Human (FIH) study for PRP in patients with advanced solid tumors. Initial discussion held previously with the Clinical Investigator confirmed the remaining development activities to be conducted by the Company prior to filing the clinical trial application for the FIH study. This includes the finished drug product manufacture and validation of the bioanalytical method to analyze the pharmacokinetics (movement of drug within the body) of PRP during the study.
The Peter Mac Cancer Center is a world leading cancer research, education and treatment center and Australia’s only public health service dedicated to caring for people affected by cancer. They have 3,900 employees, including more than 750 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer. They are well placed to support the Company’s goals for a world first clinical study of PRP, as a long term, proenzyme therapy for the treatment and prevention of metastatic cancer from solid tumors by targeting and eradicating cancer stem cells, free from side effects normally associated with standard treatment approaches.
“We are pleased to have engaged in positive initial discussion with Professor Mark Rosenthal, Director and FIH Clinical Study Investigator at the Peter Mac Cancer Center,” said James Nathanielsz, BAS, MEI, Propanc’s Chief Executive Officer. “We are excited about the opportunity to work with a world class facility like Peter Mac, and it was great to see our mutual excitement about a potential world first study for PRP as a new therapeutic approach to treat and prevent metastatic cancer from solid tumors. Our plan is to undertake the FIH study in Australia, given the favorable R&D cashback benefit where we will receive 43% of our R&D expenditure on local activities, as well as approval from the Australian Government for reimbursement some overseas activities as well. We will then plan to undertake subsequent clinical studies in Europe, as the preeminent region behind the USA, where we will undertake a Pre-IND meeting with the US Food and Drug Administration once we have clinical data from our FIH study. Achieving this exciting development stage in the not-too-distant future could prove transformative for the Company, and its shareholders.”
Propanc is set to capitalize on favorable government incentives from the Australian government for future product and clinical development of PRP, receiving a 43.5% cash back benefit on all local R&D activities conducted in Australia. Furthermore, a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science Australia to receive up to a 43.5% “cash back” benefit from overseas R&D expenses. Overseas activities to be undertaken include validation of the pharmacokinetics method for PRP and its manufacture of the finished product for the FIH study.
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 pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.
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 its anti-cancer lead product candidate, PRP, please click on the following link: http://www.propanc.com/news-media/video.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the planned studies and market projections described above and the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process; the availability of financing; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary business partners; the impact of competition; the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the SEC.
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Released August 15, 2023