Propanc Biopharma Purchases Pharma Grade Raw Materials for PRP Manufacture in Preparation for Phase I First-In-Human Study

Rhea-AI Summary

Propanc Biopharma, Inc. (OTCQB: PPCB) has announced the procurement of pharmaceutical-grade raw materials for its Phase I First-In-Human study targeting advanced cancer patients with solid tumors. Approximately 0.5kg of trypsinogen and 2.4kg of chymotrypsinogen have been acquired, with a second batch scheduled for mid-year. This marks a significant step in developing its proprietary PRP treatment, which aims to inhibit tumor growth. The initial study will involve 30 to 40 patients, followed by two Phase II studies for pancreatic and ovarian tumors.

Positive

• Procurement of raw materials indicates progress toward Phase I study.
• PRP development aims to offer a new treatment option for metastatic cancer.
• Collaboration with experienced suppliers could enhance production quality.

Negative

• Dependence on third parties for essential services.
• Risks associated with regulatory approvals and clinical trials.
• Financial uncertainty related to ongoing debt financing.

MELBOURNE, Australia--(BUSINESS WIRE)-- 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.

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

Forward-Looking Statements

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 periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005064/en/

Investor Relations and Media:

Mr. James Nathanielsz

Propanc Biopharma, Inc.

irteam@propanc.com

+61-3-9882-0780

Source: Propanc Biopharma, Inc.

FAQ

What is the significance of the raw materials purchase by PPCB?

The purchase of raw materials is crucial for developing PRP for an upcoming Phase I study on advanced cancer patients, demonstrating progress in clinical development.

How many patients will be involved in PPCB's Phase I FIH study?

The Phase I First-In-Human study will treat approximately 30 to 40 patients with advanced solid tumors.

What is the main goal of Propanc's PRP treatment?

PRP aims to inhibit the growth of tumor cells and provide a long-term therapeutic option for patients suffering from metastatic cancers.

What are the risks mentioned in PPCB's press release?

The press release highlights risks related to regulatory approvals, clinical trial outcomes, and financial uncertainties due to debt reliance.