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PRX302
PRX302 is a serine protease that selectively activates protease-activated receptor 1 (PAR1) in the prostate to induce localized tissue destruction and immune activation.
PRX302 is a serine protease that selectively activates protease-activated receptor 1 (PAR1) in the prostate to induce localized tissue destruction and immune activation. Used for Benign prostatic hyperplasia (BPH), Prostate cancer (early-stage).
At a glance
| Generic name | PRX302 |
|---|---|
| Also known as | topsalysin, Topsalysin |
| Sponsor | Sophiris Bio Corp |
| Drug class | Engineered serine protease / PAR1 activator |
| Target | PAR1 (Protease-Activated Receptor 1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PRX302 is a genetically engineered protease designed to target and activate PAR1 specifically in prostate tissue, leading to localized cell death and recruitment of immune cells. This mechanism aims to trigger an anti-tumor immune response while minimizing systemic toxicity by concentrating activity in the prostate. The drug is administered via transurethral injection directly into the prostate gland.
Approved indications
- Benign prostatic hyperplasia (BPH)
- Prostate cancer (early-stage)
Common side effects
- Dysuria / urinary discomfort
- Hematuria
- Urinary retention
- Prostatitis / urinary tract infection
- Pelvic pain
Key clinical trials
- Prostate Specific Antigen Levels of Individuals Living in Rural Areas
- Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer (PHASE2)
- Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia (PHASE2)
- PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer (PHASE1)
- Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH (PHASE3)
- Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer (PHASE2)
- Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) (PHASE1, PHASE2)
- An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |