topsalysin (PRX302) / Sophiris Bio - LARVOL DELTA

Minimally Invasive Therapy: What Is The Status In 2021 - What's Coming, What's Going? (PubMed, Aktuelle Urol) - "For instance, transurethral needle ablation, transurethral microwave thermotherapy, intraprostatic botulinum toxin A or PRX302 injections as well as prostatic stents are no longer recommended. In contrast, the European Association of Urology is currently recommending UroLift, Aquablation and prostatic artery embolisation, which achieve significant long-term improvements in functional parameters while providing a good safety profile and preserved sexual function. Promising data are also available for the temporarily implanted nitinol device (iTIND), Rezūm, intraprostatic injection of fexapotide triflutate and transperineal laser ablation of the prostate, but the efficacy and safety of these procedures need to be confirmed in further studies."

Journal • Urology

A state-of-art review on the preservation of sexual function among various minimally invasive surgical treatments for benign prostatic hyperplasia: Impact on erectile and ejaculatory domains. (PubMed, Investig Clin Urol) - "These minimally invasive BPH therapies can be largely be divided into those with cavitating technology (Rezum, Histotripsy, Aquablation), intra-prostatic injections (Botulinum neurotoxin Type A, Fexapotide Triflutate, prostate specific antigen-activated protoxin PRX-302), and mechanical devices which include intraprostatic stents (Urospinal 2™, Memotherm™, Memokath™, and Allium triangular prostatic stent™) and intraprostatic devices (iTIND™, Urolift™), as well as prostatic artery embolization. Published literature on these technologies showed reasonable preservation of erectile function with limited data reported on ejaculatory domain. Further validation of the performance of these novel minimally invasive treatment options for LUTS due to BPH in well-designed and multi-centre studies are desired, to evaluate their role (or lack of such a role) in clinical practice and whether these BPH therapies can provide equivalent standard or better than TURP."

Journal • Review • Benign Prostatic Hyperplasia • Sexual Disorders

Microparticle Encapsulation of a Prostate-Targeted Biologic for the Treatment of Liver Metastases in a Preclinical Model of Castration-Resistant Prostate Cancer. (PubMed, Mol Cancer Ther) - "Microparticle encapsulation prevented PRX302 from immediately interacting with GPI-anchored proteins as demonstrated in a competition assay, which resulted in an increased therapeutic index and significant anti-tumor efficacy following a single dose of PRX302-loaded microparticles in a preclinical model of prostate cancer liver metastasis with no obvious toxicity. These results document PRX302 released from PLGA microparticles demonstrate in vivo anti-tumor efficacy in a clinically-relevant preclinical model of metastatic prostate cancer."

Journal • Preclinical • Benign Prostatic Hyperplasia • Genito-urinary Cancer • Hematological Disorders • Hepatology • Liver Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK3

Sophiris Bio receives positive feedback from FDA regarding phase 3 localized prostate cancer clinical trial design (PRNewswire) - "Sophiris Bio Inc...announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer....The study will enroll approximately 700 patients with a confirmed diagnosis of localized intermediate risk disease, to be equally randomized to receive a single administration of either topsalysin or placebo."

Clinical protocol • FDA event

Sophiris Bio reports second quarter 2019 financial results and recent corporate highlights (PRNewswire) - "'During the second quarter of 2019, we received positive feedback from the EMA regarding the design of our Phase 3 clinical trial for localized prostate cancer which was a significant step forward in our development of topsalysin'....The company is now actively engaged in discussions with the FDA on the design of the proposed Phase 3 clinical trial. The goal is to conduct a single Phase 3 trial, which if successful, will provide the clinical data for approval in both the US and Europe."

Clinical protocol • New P3 trial

Investigational procedures in benign prostatic hypertrophy. (PubMed, Curr Opin Urol) - "Many new techniques are poised to be introduced to the BPH market over the coming years. The unique risk/benefit profiles as well as associated clinical outcomes of each will need to be studied in detail in order to help identify proper roles in the management of patients with symptomatic disease."

Biomarker • Journal

Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer (clinicaltrials.gov) - P2; N=38; Completed; Sponsor: Sophiris Bio Corp; Active, not recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Apr 2019

Clinical • Trial completion • Trial completion date

"Have you looked at @sophiris_bio ? Topsalysin looks like a good fit in the @Merck portfolio??" (@EatTradeTravel)