18:29 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Patient death in Sophiris' prostate cancer trial deemed unrelated to topsalysin

Sophiris Bio Inc. (NASDAQ:SPHS) said that the patient death reported in June from a Phase IIb trial evaluating topsalysin (PRX302) to treat localized prostate cancer is unlikely to be related to either topsalysin or the...
14:54 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Sophiris reports patient death in prostate cancer trial

Sophiris Bio Inc. (NASDAQ:SPHS) reported a patient death in an open-label, U.S. and U.K. Phase IIb trial evaluating topsalysin (PRX302) to treat localized prostate cancer. The company said it is evaluating the cause of death....
07:00 , Jul 18, 2016 |  BC Week In Review  |  Clinical News

Topsalysin: Additional Phase IIa data

Data from an open-label, U.K. Phase IIa trial in 18 patients with localized prostate cancer showed that a single intraprostatic injection of topsalysin led to complete ablation of the targeted tumor with no evidence of...
08:00 , Feb 8, 2016 |  BC Week In Review  |  Clinical News

Topsalysin: Preliminary Phase IIa data

Preliminary data from 7 patients in an open-label, U.K. Phase IIa trial showed that a single intraprostatic injection of topsalysin led to 1 complete ablation of the tumor at 6 months. Additionally, 3 patients had...
08:00 , Nov 16, 2015 |  BC Week In Review  |  Clinical News

Topsalysin: Phase III data

The double-blind, international Phase III PLUS-1 in 479 patients with moderate to severe BPH showed that a single intraprostatic injection of 0.6 ug/g PRX302 met the primary endpoint of improving IPSS total score from baseline...
07:00 , Jun 8, 2015 |  BC Week In Review  |  Clinical News

Topsalysin: Phase IIa started

Sophiris began an open-label, U.S. Phase IIa trial to evaluate PRX302 in about 20 patients. Sophiris Bio Inc. (NASDAQ:SPHS), La Jolla, Calif.   Product: Topsalysin ( PORxin ) ( PRX302 ) (formerly PSA-PAH1 )  ...
08:00 , Jan 19, 2015 |  BC Week In Review  |  Clinical News

Topsalysin: Interim Phase III data

An interim analysis by the IDMC of the double-blind, vehicle-controlled, international Phase III PLUS-1 in 479 patients with BPH showed that a single intraprostatic injection of 0.6 µg/g PRX302 did not meet the pre-defined efficacy...
07:00 , Sep 8, 2014 |  BC Week In Review  |  Clinical News

Topsalysin: Completed Phase III enrollment

Sophiris completed enrollment in the double-blind, vehicle-controlled, international Phase III PLUS-1 trial evaluating a single intraprostatic injection of 0.6 ug/g prostate PRX302. The company said the trial enrolled at least 440 patients as designed, but...
08:00 , Nov 4, 2013 |  BC Week In Review  |  Clinical News

Topsalysin: Phase III started

Sophiris began the double-blind, placebo-controlled, international Phase III PLUS-1 trial to evaluate a single intraprostatic injection of 0.6 µg/g prostate PRX302 in about 440 patients. Kissei has exclusive, Japanese rights to PRX302 to treat BPH,...