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Re: None

Friday, 09/25/2015 12:11:16 PM

Friday, September 25, 2015 12:11:16 PM

Post# of 2804248
SPHS keep an eye.Cancer Phase3!,and i believe can make a several times investment return the short term.Phase3 cancer,news can hit anytime.very cheap (17m cap),but still very solid.:

(As of August 5, 2015, the registrant had 16,844,736 common shares (no par value) outstanding).

At June 30, 2015, we had cash, cash equivalents and securities available-for-sale of $13.2 million and net working capital of $11.6 million. We expect that our cash, cash equivalents and securities available-for-sale as of June 30, 2015 will be sufficient to fund our operations

"Enrollment and dosing in the study were completed in September 2014",exactly 52 weeks,news can hit anytime:

December 15, 2014
Sophiris Bio Reports Administrative Interim Analysis for the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia
SAN DIEGO & VANCOUVER, British Columbia--(BUSINESS WIRE)-- Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of symptoms of benign prostatic hyperplasia (BPH, enlarged prostate) and the treatment of localized prostate cancer, today announced findings from an administrative interim analysis of efficacy in its ongoing Phase 3 "PLUS-1" trial of PRX302 as a treatment for lower urinary tract symptoms of BPH. The Independent Data Monitoring Committee (IDMC) reported that a predefined efficacy threshold following treatment was not achieved. This administrative interim analysis was conducted specifically for planning subsequent clinical trials. The ongoing "PLUS-1" study is unaffected by this recommendation, and all patients in the study will continue to be followed to enable the evaluation of the primary efficacy endpoint at 52 weeks.

"Patients will continue to be followed for the duration of the study to evaluate the International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks - the primary endpoint of the study," stated Randall Woods, President and CEO of Sophiris. "We expect to be able to provide further commentary on the activity of PRX302 once the study is complete and all the data through 52 weeks are unblinded and analyzed in the fourth quarter of 2015."

The IDMC completed the planned, protocol-specified administrative analysis of efficacy based on the IPSS change from baseline to Week 12 for all 479 patients dosed in the study. Simultaneously with this administrative interim efficacy analysis, the IDMC completed its fifth and final periodic analysis of unblinded safety data and reported no safety concerns to Sophiris. There were no events of sepsis reported post administration of study drug in this trial.

The IDMC conveyed this recommendation to Sophiris in a manner that would not unblind the study nor reveal the actual measured treatment effect. Sophiris and others directly involved in the study will remain blinded to treatment group assignment as the 52 week monitoring period continues until after the last patient has completed the study, which is anticipated to be in September 2015.

The Phase 3 "PLUS-1" study is an international, multicenter, randomized, double-blind, and vehicle-controlled trial to assess the safety and efficacy of a single intraprostatic administration of PRX302 (0.6 µg/g prostate) for the treatment of BPH. Enrollment and dosing in the study were completed in September 2014. The primary endpoint is the IPSS total score change from baseline over 52 weeks. Secondary endpoints include Qmax (maximum urine flow) change from baseline over 52 weeks.


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