Propanc Biopharma Clears Path for World-First Phase 1b Clinical Study of Breakthrough Cancer Therapy PRP
Sentiment and the balance of points
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Rhea-AI Summary
Propanc Biopharma (Nasdaq: PPCB) has begun finalizing the clinical trial protocol and conducting a feasibility assessment for a First‑In‑Human, Phase 1b study of its lead candidate PRP in up to 40 patients with advanced solid tumors across multiple centers in Australia.
Avance Clinical will lead preparatory activities, including reviewing the Investigator’s Brochure, preparing a Briefing Document, and finalizing the Clinical Trial Protocol. The open‑label study will use a two‑part dose escalation and expansion design, with weekly IV dosing and a BOIN approach to identify maximum tolerated and recommended doses. A Clinical Trial Application submission is planned for Q4 this year.
Positive
- Phase 1b FIH study preparation initiated for PRP in up to 40 advanced solid tumor patients
- Avance Clinical appointed to lead multicenter trial preparatory activities across Australia
- Clinical Trial Application submission for PRP Phase 1b study planned for Q4 this year
Negative
- Lead candidate PRP remains at First‑In‑Human, Phase 1b planning stage
- Clinical Trial Application for the PRP study has not yet been submitted
Details
News Market Reaction – PPCB
On Aug 18, the day this news came out, PPCB closed 1.74% below the previous close. Relative volume reached 4.3x the daily average during tracking.
Data tracked by StockTitan Argus for the Aug 18 session.
Key Figures
- Study phase
- Phase 1b
- First-in-human PRP study
- Patient population
- Up to 40 patients
- Advanced cancer patients with solid tumors
- CTA timing
- Q4 this year
- Planned Clinical Trial Application submission
- Dose levels
- Up to 5
- Planned escalation in Part A
- Dosing schedule
- Days 1, 8, 15 and 22
- Weekly intravenous infusion schedule
- Treatment cycle
- 28 days
- PRP treatment cycle
Historical Context
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PRP positioning for RAS-driven cancers and reported preclinical efficacy and survival findings
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Preclinical PRP models reported tumor inhibition and survival benefit in pancreatic cancer
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First tranche completed under the previously approved $5.0 million share repurchase program
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Peer-reviewed publication evaluated recombinant proenzymes for potential therapeutic use
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Non-binding MOU with Avance Clinical supported planned Phase 1b trial preparation
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacokinetics medical
pharmacodynamics medical
bayesian optimal interval medical
dose limiting toxicity medical
maximum tolerated dose medical
clinical trial application regulatory
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Avance Clinical to Lead Preparatory Activities for Multi-Center Investigation Across Australia
MELBOURNE, Australia, Aug. 18, 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 has commenced finalization of a clinical trial protocol and will conduct a feasibility assessment for its First-In-Human (FIH), Phase 1b clinical study of PRP in up to 40 advanced cancer patients suffering from solid tumors. Preparatory activities for the multi-trial center investigation will be led by Avance Clinical Pty Ltd and will consist of a detailed review of the Company’s Investigator’s Brochure (IB), preparation of a Briefing Document from the IB, as well as finalization of a Clinical Trial Protocol using the jointly prepared Clinical Trial Synopsis which summarizes the design of the 40-patient study. The documents will be provided to Investigators in Clinical Trial Centers located across Australia for the world-first study to obtain detailed and thorough feedback as part of a feasibility assessment prior to the submission of a Clinical Trial Application planned for Q4 this year.
The world-first clinical study is a Phase 1b, open‑label, dose escalation and dose expansion study of PRP in patients with advanced solid tumors. It will consist of a multicenter, open-label, two-part (dose escalation, Part A, and dose expansion, Part B) study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of PRP in participants with advanced solid tumors. PRP will be administered as a weekly intravenous (IV) infusion (Days 1, 8, 15 and 22 of every 28-day treatment cycle). Treatment with PRP may continue until a withdrawal criterion is met. Part A will use a Bayesian Optimal Interval (BOIN) design with target dose limiting toxicity (DLT) probability, with backfill (BF) allowed (BF-BOIN), to identify the maximum tolerated dose (MTD), if reached, and/or up to two recommended doses for optimization/expansion (RDO) of PRP. Up to 5 dose levels are planned for escalation. Following determination of the RDO(s) in Part A, Part B will further evaluate the safety, tolerability, and preliminary antitumor activity of PRP at the selected doses into one or more tumor specific expansion cohorts.
“The Feasibility Assessment in preparation of our FIH, Phase1b clinical study for PRP is a major step towards a significant, transformative milestone for the Company in the advancement of a first-in-class therapy for the treatment and prevention of metastatic cancer from solid tumors, such as pancreatic, ovarian and refractory prostate cancers,” said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. “The design of the Phase 1b study has been undertaken with the Company’s research and development team, our partners, and will be ably led by the Company’s appointed CRO, Avance Clinical, who have extensive experience in this field. Many hours have been spent so far preparing the Company’s supporting documents and it reflects the hard work and dedication for nearly two decades incorporating scientific research, non-clinical and clinical evidence, formulation development and API (active pharmaceutical ingredient) purification, and manufacturing process development to be ready for the Phase 1b study. We look forward to further announcements as we advance towards the submission of the CTA (Clinical Trial Application) and commencement of the GMP manufacture of PRP this year. I have every confidence these activities will result in significant anticipatory interest among the medical and scientific communities with a world-first therapeutic that reverses the malignancy of cancer cells and leaves healthy cells intact, free from side effects often observed with standard treatment regimen, whilst preventing cancer from returning and spreading. Metastatic cancer remains the single most common cause of death among sufferers from solid tumors.”
About Propanc Biopharma, Inc.
Propanc Biopharma, Inc. (Nasdaq: PPCB) is developing a novel approach to preventing cancer recurrence and metastasis by targeting and eradicating cancer stem cells through proenzyme activation. The Company’s lead product candidate, PRP, is designed to address the underlying drivers of cancer proliferation and spread.
More information: www.propanc.com
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding its market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors, made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Forward-looking statements are not guarantees of future actions or performance. Actual results may differ materially from those in the forward-looking statements because of several factors, including, without limitation, risks and uncertainties related to market conditions, as well as those risks described under “Risk Factors” in the prospectus related to the proposed offering and those described in the Company’s filings with the SEC. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
Company:
Propanc Biopharma, Inc.
James Nathanielsz
+61-3-9882-0780
Investor Contact:
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