Hard to believe its true - read here if you understand, what a...

Hard to believe its true - read here if you understand, what a drug or drug combination can do, to rapidly stop cancer metastasizing in the human body.

This is a Clinical Trial at highly reputable QIMR Berghofer, Brisbane. The company KAZIA Therapeutics, left Australia, sometime ago - and you need to be able to trade US stocks - if interested.  The news has just fallen in the US - the SP is up 50%, to a make a total market cap of us$15 million.

The information is in one patient - but it is dramatic, and I believe this to be a genuine breakthrough. Circulating Tumor Cells shed or break - from the cancer tumor to form clusters and move around the blood stream - to seed new tumors. It pre clinic research, the dual drug combination, also impacts strongly on the solid primary tumor. Stay tuned...

What is being said here is really of high significance and will have big ramifications around the world, seemingly.

Provided by PR Newswire  Jul 9, 2025, 10:00:00 PM
Kazia Therapeutics Reports Early Efficacy Data from First Triple-Negative Breast Cancer Patient Receiving Paxalisib Combination Regimen achieving >50% Reduction in Circulating Tumor Cells in Phase 1b Trial
Kazia Therapeutics Reports Early Efficacy Data from First Triple-Negative Breast Cancer Patient Receiving Paxalisib Combination Regimen achieving >50% Reduction in Circulating Tumor Cells in Phase 1b Trial

PR Newswire
SYDNEY, July 9, 2025
SYDNEY, July 9, 2025 /PRNewswire/ -- Kazia Therapeutics (NASDAQ: KZIA) is pleased to announce preliminary results from the first patient in its Phase 1b trial evaluating a combination regimen of Paxalisib, pembrolizumab (Keytruda®, and standard chemotherapy after completing Cycle 1 (21 days) of dosing. The patient, a 61-year-old woman with metastatic triple-negative breast cancer localized to the left upper lobe of the lung, has shown highly encouraging preliminary results at 21 days, with a >50% reduction in circulating tumor cells (CTCs) and a notable decrease in CTC clusters.
The early data in this first patient closely mirror the mechanistic preclinical findings published in Molecular Cancer Therapeutics (https://aacrjournals.org/mct/articl...epleting-the-Action-of-EZH2-through-PI3K-mTOR), which highlight that Paxalisib, when combined with immunotherapy, significantly disrupted both single CTCs and multicellular clusters in preclinical models.
Key Highlights
- Patient Profile: 61-year-old female, metastatic triple-negative breast cancer (lung metastasis).
- Investigational Regimen: Paxalisib, pembrolizumab, and chemotherapy.
- Results at Day 21 (End-of-Cycle 1):

• >50% reduction in total CTC count.
• Comparable reduction in CTC clusters—these aggregates are associated with heightened metastatic potential.
• Reduction in the mesenchymal phenotype of the remaining CTCs; this phenotype is one of the hallmarks of aggressive metastatic seeding cancer cells.
• First-in-human data support potential for potent CTC mobilization suppression by this combination.

Clinical Significance of Patient Data
CTC clusters have long been recognized as critical mediators of metastasis and markers of poor prognosis. They are known to resist apoptosis, evade immune detection, and seed new tumor sites with exceptional efficiency. Notably, standard chemotherapy has been shown in some studies to transiently increase CTC and cluster counts within the first cycle, with levels sometimes doubling before normalizing after cycle two. In contrast, immunotherapy alone has demonstrated variable impact, often showing delayed or modest effects on CTCs, likely due to immune-mediated mechanisms over weeks to months.
In this case, the combination regimen of Paxalisib and immunotherapy achieved a rapid reduction in both CTC numbers and clusters as well as a reduction in the mesenchymal phenotype—an outcome not typically seen with chemotherapy or immunotherapy alone after only 21 days of treatment. This early clinical data reflects mechanistic synergy consistent with the preclinical data described in the MCT manuscript.
Dr. John Friend, MD, Chief Executive Officer of Kazia Therapeutics, said "It is very exciting to see our extensive preclinical research translate into such positive early data in this first patient receiving a combination of Paxalisib and immunotherapy. The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial."
Dr. Friend continued "CTC clusters are emerging as key drivers of metastatic spread—they're 20–100X more efficient at seeding than single CTCs—and the sharp decline we're seeing is truly encouraging. We believe this combination may offer a meaningful early intervention against systemic disease progression."
Next Steps
- Explore potential relationship between CTC kinetics and radiographic responses
- Enrollment continues in the Phase Ib study, expanding cohort size to assess safety, tolerability, and pharmacodynamics
- Planned comprehensive analysis of immune microenvironment and CTC kinetics across all patients through serial monitoring
- Longer-term follow-up will include imaging, progression-free survival, and assessment of correlation with molecular biomarkers
For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, [email protected], +1-201-786-8795.