Sophiris Bio Up 113% After Successful Results From Phase 2a Trial Of Topsalvsin In Localized Prostate Cancer

Sophiris Bio Inc. SPHS, a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, revealed the biopsy results from all 18 patients enrolled in the Phase 2a proof of concept study of topsalysin in localized prostate cancer. According to the company, the one-time administration of topsalysin was well tolerated with no serious adverse events and no new safety signals being reported.

Sophiris Bio said Topsalysin demonstrated an ability to ablate tumor cells in 50 percent of patients (9/18 patients) six months after treatment in a patient population with pre-identified, clinically significant prostate cancer. The company said that the results supported advancing topsalysin into a Phase 2 study to confirm dose and optimize delivery.

Shares of the company surged 126 percent to $2.50 in the pre-market on Friday.

The company's COO and Head of R&D, Allison Hulme, said, "The breakthrough for us is the ability to inject topsalysin, an enzymatically-activated ablative agent, directly into the identified tumor using imaging technology. Topsalysin has been engineered to be activated only by enzymatically-active PSA, which is only found in the prostate tissue. We believe that with the favorable side effect profile observed to date, topsalysin has the potential to become a focal targeted therapy for the ablation of localized prostate cancer while avoiding many of the complications and side effects associated with radical treatments that are aimed at the entire prostate."

Similarly, Dean, Faculty of Medical Sciences, Mark Emberton, commented,"These promising early results open up the possibility of treating early prostate cancer by the simple administration of an injection into the prostate - something that could be done in an office setting."