Positive Results from Sophiris’ Phase 3 Trial of BPH Treatment Topsalysin Presented at Conference

Positive Results from Sophiris’ Phase 3 Trial of BPH Treatment Topsalysin Presented at Conference

Sophiris recently presented positive results from a Phase 3 clinical trial of its lead drug candidate topsalysin (PRX302) at the 16th Annual Needham Healthcare Conference April 4-5 in New York. The investigational drug was shown to improve the symptoms of benign prostatic hyperplasia (BPH).

While 36 million men in the U.S. are affected by BPH, current drug treatments are associated with adverse side effects, such as sexual dysfunction. Surgery, one of the most successful BPH treatments, can also cause problems, such as incontinence and impotence.

Topsalysin was designed to specifically prevent the growth of prostate cells, which characterizes BPH. The drug binds to the surface of prostate cells but requires PSA, a protein produced by these cells, to become active. Topsalysin causes the death of localized prostate cells but without damaging neighboring tissues and nerves. This strategy increases drug safety while it avoiding side effects.

According to the company, topsalysin was designed to be a single treatment for the long-term relief of BPH symptoms. The drug is also not expected to affect patients’ quality of life and has minimal side effects.

In the Phase 3 clinical trial, a single injection of topsalysin into the prostate significantly improved BPH symptoms in 239 patients.

Over 12 months of follow-up, there was a significant improvement in the International Prostate Symptom Score (IPSS) in those patients receiving the drug compared to those who received an injection of solution without topsalysin.

Measurements of maximum urine flow (Qmax) showed an overall improvement of 1.77 mL per second in the patients receiving topsalysin. When asked about quality of life, treated patients reported a 1.6 to 1.7 point improvement.

Topsalysin delivered through injection into the prostate targets only the prostate tissue, limiting drug circulation in the body and the risk of side effects.  This study also showed that topsalysin appears to be safe and well-tolerated. These results are an important step for final U.S. Food and Drug Administration (FDA) approval.

The 16th Annual Needham Healthcare Conference is restricted to institutional investors and venture capital firms. But Sophiris has made its presentation at the conference available on the company’s website here for 90 days.

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Teresa F. Pais holds her PhD in Biomedical Sciences from University of Porto. She has worked in innate immune responses in the context of both infection and neurodegeneration. Currently, she is a researcher at Instituto de Medicina Molecular where she investigates inflammatory processes in the brain.

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