Updated
September 13th, 2019

Prostate Cancer Treatment Closer to Europe Marketing Approval

Sophiris Bio Topsalysin (PRX302) is a focal therapy to treat patients with intermediate risk, localized prostate cancer

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A biopharmaceutical company announced that it has received formal scientific advice from the European Medicines Agency (EMA) regarding a proposed design of a Phase 3 clinical trial to evaluate the potential of Topsalysin (PRX302). 

Topsalysin, which is produced by Sophiris Bio, Inc., is a targeted focal therapy to treat patients with intermediate-risk, localized prostate cancer. 

Randall Woods, CEO of Sophiris, said in a press release, "We believe that data from a single Phase 3 trial, if successful, will be sufficient to support market approval in Europe."   

This is important news since aside from non-melanoma skin cancer, prostate cancer is the most common cancer among men in the United States, says the Centers for Disease Control and Prevention (CDC). 

Topsalysin (PRX302), an innovative, "First-in-Class" transmembrane pore-forming protein, was genetically modified to be activated only by enzymatically-active prostate-specific antigen, which is produced in large quantities within the prostate of men with prostate cancer. 

The Phase 3 study will enroll 700 male patients with a confirmed diagnosis of intermediate risk disease. The primary endpoint for the study will be the proportion of patients at 12 months who have failed treatment, defined as histological progression of disease resulting in the need for alternative intervention, per an independent central adjudication panel.   

Topsalysin has the potential to provide targeted focal therapy for the ablation of localized prostate cancer lesions while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. 

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The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in software to co-register previously obtained mpMRI images with real-time three-dimensional ultrasound images, enables urologists to more accurately locate tumors within the prostate when taking biopsies. 

This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate. 

The targeted focal treatment of prostate cancer is in line with current treatment trends for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ and organ function as possible.

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Sophiris Bio Inc. is a late-stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases.

Topsalysin has completed two Phase 2 clinical trials for the focal treatment of localized prostate cancer and has completed one Phase 3 study of topsalysin for the treatment of the lower urinary tract symptoms of benign prostatic hyperplasia.