Interim data indicates Sophiris drug may not be effective

(Reuters) - Sophiris Bio Inc lost about 80 percent of its market value after interim data showed that its only compound was not effective in treating lower urinary tract symptoms of enlarged prostate. Monday's announcement cast doubts on whether the company's drug could meet the main goals of its ongoing late-stage study. "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," Sophiris Chief Executive Randall Woods said. Sophiris Bio, which had touted benign prostatic hyperplasia (BPH) as a blockbuster indication, said the ongoing late-stage study of the drug was "unaffected" by the data. The company was not immediately available for more comments. San Diego-based Sophiris has been focusing on developing the drug PRX302 since 2009, when it bought the license to the compound from UVIC Industry Partnerships Inc and The Johns Hopkins University. Sophiris Bio, which used to be Canada's Protox Therapeutics Inc, had earlier said the drug showed relief in symptoms of BPH from a single treatment in a mid-stage study. A unit of the National Institutes of Health quoted Urology Care Foundation as saying BPH, commonly known as enlarged prostate, affects about half the men in their fifties and up to 90 percent of men older than 80. Men who suffer from BPH often have problems urinating. Corrective surgeries and current medication have side-effects including sexual dysfunction and heart problems. PRX302, designed to be injected directly into the prostate, is less invasive than surgery and more effective and better-tolerated than approved drugs, the company said. The stock fell 79.7 percent to 57 cents in early trading, its lowest since it went public in August 2013. More than 1.5 million shares changed hands by 10:50 a.m. ET, more than 16 times their 10-day moving average. (Reporting by Vidya L Nathan in Bengaluru; Editing by Savio D'Souza and Don Sebastian)