Propanc Biopharma Advances Clinical Development Preparation for PRP Phase 1b First-In-Human Study in Up to 50 Advanced Cancer Patients
Key Highlights
- ➤Propanc targets February 2027 for first clinical site initiation and patient screening
- ➤Phase 1b study planned for up to 50 advanced cancer patients with solid tumors
- ➤Protocol documentation targeted for early November 2026; first-site ethics submission planned during November
- ➤Regulatory activities are targeted for January 2027, subject to clinical and operational requirements
- ➤PRP combines trypsinogen and chymotrypsinogen A in a fixed 1:6 ratio
Expert Statements
James Nathanielsz, Chief Executive Officer of Propanc Biopharma
“The continued advancement of these activities represents an important step towards transitioning PPC-001 from preclinical development into clinical evaluation in patients with advanced cancer.”
James Nathanielsz, Chief Executive Officer of Propanc Biopharma
“We are contacting multiple sites across Australia, and providing prospective clinical investigators a single, source-traceable account of the scientific rationale and the non-clinical and prior clinical evidence supporting PPC-001, together with the strategy for the proposed First-In-Human Study.”
James Nathanielsz, Chief Executive Officer of Propanc Biopharma
“I am pleased to confirm that we are fielding strong interest in participating in and acting as lead investigators to support the HREC for the world-first investigation into PPC-001 as a long-term therapy for the treatment and prevention of metastatic cancer.”
James Nathanielsz, Chief Executive Officer of Propanc Biopharma
“The Propanc management team are expending every effort to rapidly progress PPC-001 into the clinic, and these near-term milestones are expected to be transformative for the Company, its shareholders and ultimately, we hope for patients and their families as well.”
MELBOURNE, Australia, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company focused on developing novel treatments for chronic diseases including recurrent and metastatic cancer, today announced it is advancing its clinical development program for PRP (Company Code Name: PPC-001, Propanc Proenzyme Combination) its investigational proenzyme-based therapeutic candidate, as the Company preparations continue for its planned Phase 1b, First-In-Human study in up to 50 advanced cancer patients with solid tumors. Several key workstreams are underway, including clinical trial protocol development, preparation of the Investigator’s Brochure (IB), clinical site feasibility assessments, vendor selection, and regulatory and Human Research Ethics Committee (HREC) submission plans.
These activities support the Company's preparations for the next phase of clinical development, with particular emphasis on finalizing the documentation, operational infrastructure and regulatory requirements necessary to initiate the proposed study. The Company's clinical development activities are progressing across several interconnected workstreams: * Clinical documentation: Preparation of the final clinical protocol and Investigator’s Brochure is ongoing, with final protocol documentation targeted for early November 2026. * Investigator’s Brochure: Finalization is progressing, with additional stability information relating to clinical samples and the clinical formulation scheduled for incorporation during November. * Clinical site preparation: Site feasibility and identification activities are progressing well with a first meeting scheduled alongside site budget negotiations and collection of essential regulatory documentation. * Clinical operations: Vendor selection and contracting activities are progressing, together with the preparation of study plans and clinical data management systems. * Ethics and regulatory submissions: The current project schedule targets the first-site ethics submission process during November 2026, followed by regulatory activities in January 2027. The Company currently targets February 2027 for its first clinical site initiation visit followed by its first patient screening, subject to completion of the necessary clinical, regulatory, ethics and operational requirements.
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