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SPHS UP 75% in AH on news: Sophiris Bio Reports Successful Results from Completed Phase 2a Study of Topsalysin in Localized Prostate Cancer
Topsalysin successfully ablated tumor cells in patients with clinically significant localized disease

http://www.prnewswire.com/news-releases/sophiris-bio-reports-successful-results-from-completed-phase-2a-study-of-topsalysin-in-localized-prostate-cancer-300282594.html

Investor webcast scheduled for today at 2:00 p.m. Pacific Time

16:00 ET from Sophiris Bio Inc.


SAN DIEGO and VANCOUVER, British Columbia, June 9, 2016 /PRNewswire/ -- Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, today announced the biopsy results from all 18 patients enrolled in the Phase 2a proof of concept study of topsalysin in localized prostate cancer. The one-time administration of topsalysin was well tolerated with no serious adverse events and no new safety signals being reported. 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 results support advancing topsalysin into a Phase 2 study to confirm dose and optimize delivery.

"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," according to Dr. Mark Emberton, Investigator, Dean, Faculty of Medical Sciences, University College London and Honorary Consultant Urologist at University College London Hospital NHS Foundation Trust.

All 18 patients enrolled completed the study. Biopsy data at six months following treatment showed that:

Two men experienced complete ablation of their targeted tumor with no evidence of any tumor remaining at 6 months;
Seven men experienced a partial response, defined as either a reduction in the maximum cancer core length or a reduction in Gleason pattern;
Nine patients had no response to treatment.
"It was impressive to observe complete tumor ablations in this proof of concept study. We have demonstrated that topsalysin can safely ablate prostate tumor cells, so these responses increase our confidence that topsalysin could obviate or prolong the time to the need for radical therapy in this patient population," stated Dr. Hashim Ahmed, Principal Investigator for the study, Division of Surgery and Interventional Sciences, University College London. "With the experience from this study, we believe we can further improve responses by optimizing dosing topsalysin based on the size of the tumor and not the prostate and optimizing the delivery of topsalysin, which we will confirm in a larger Phase 2 study."

Allison Hulme, Ph.D., chief operating officer and head of research and development at Sophiris, added: "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."

The Phase 2a proof of concept study was a single-center, open-label study at University College London, which is well known for the focal treatment of prostate cancer in the UK. In this study, previously obtained multiparametric magnetic resonance images (mpMRIs) of each patient's prostate tumor lesions are mapped to real-time three-dimensional transrectal ultrasound using an elastic image-fusion software. These images are used to guide the injection of topsalysin to treat a single, histologically-proven, clinically significant prostate cancer lesion. The primary objective of the study was to evaluate the safety and tolerability, and the key efficacy variable was the change in the treated lesion on targeted biopsy after 6 months. The study was designed to assess whether topsalysin has the potential to provide patients with clinically significant, localized, low to intermediate risk prostate cancer a tissue-sparing cancer treatment that carries little in the way of side effects. A total of 18 patients were enrolled and treated in this study. Detailed results from this study will be presented at a future medical conference.

Webcast scheduled for today at 2:00 p.m. Pacific Time

The Sophiris management team will host a conference call and webcast today, June 9, at 2:00 p.m. Pacific Time to review the topsalysin prostate cancer data. Dr. Hashim Ahmed, University College London and Principal Investigator of the prostate cancer study will also participate in the call.

A live audio webcast will be accessible on the "Investor Relations" page of the Sophiris corporate website at www.SophirisBio.com. A replay will be available at the same location.