Clinical TrialMay 19, 2026, 08:47 AM
Propanc Engages CDMO for PRP GMP Manufacturing for Phase 1b Study
AI Summary
Propanc Biopharma engaged a European Contract and Development Manufacturing Organization (CDMO) for GMP manufacturing of its lead asset, PRP, for an upcoming Phase 1b First-In-Human clinical study. This pivotal step aims to advance PRP, a proenzyme therapy for advanced solid tumors, into early-stage clinical development. The company plans to file the clinical trial application later this year for the study involving 30-40 advanced cancer patients. PRP, which induces differentiation of cancer cells, previously received USFDA Orphan Drug Designation for pancreatic cancer.
Key Highlights
- Engaged a European CDMO for GMP manufacturing of lead asset PRP.
- PRP is for an upcoming Phase 1b First-In-Human study in 30-40 advanced cancer patients.
- Clinical trial application for the study planned for later this year.
- PRP is a proenzyme therapy for advanced solid tumors, administered once weekly intravenously.
- Compassionate use data showed significant life extension in terminal patients.
- Planned Phase 1b study will use significantly higher IV doses.
- PRP received USFDA Orphan Drug Designation for pancreatic cancer in 2017.
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