SAN DIEGO and VANCOUVER, British Columbia, Oct. 2, 2017 /PRNewswire/ -- Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris") today provided an update on clinical trial enrollment of its Phase 2b study of topsalysin as a treatment for men with clinically significant localized prostate cancer. Patient enrollment is near completion, and the remaining patients are being scheduled to receive treatment within the next few weeks. Sophiris expects the study will be fully enrolled by the end of October. The Company expects biopsy data from all patients dosed with the first administration of topsalysin to be available late in the first quarter of 2018.
"Interest in this study has been strong, and the remaining patients are being scheduled for treatment in the next few weeks," said Randall E. Woods, president and CEO of Sophiris. "We look forward to completing enrollment, and, assuming enrollment is completed as expected, initial biopsy results will be available toward the end of the first quarter of 2018."
Sophiris Bio Inc. is a late-stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases. Topsalysin is in Phase 2 clinical development for the focal treatment of localized prostate cancer as well as Phase 3 clinical development for the treatment of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). Topsalysin is a highly potent ablative agent that is selective and targeted in that it is only activated by enzymatically active PSA which is found in high concentrations in the transition zone of the prostate and in and around prostate tumor cells. More than 400 patients have received treatment with topsalysin, which continues to appear to be safe and well tolerated. For more information, please visit www.sophirisbio.com.
Certain statements included in this press release may be considered forward-looking, including the quote of Sophiris' President and CEO, expectations about clinical trial results, including the timing of expected results and expectations about further development of topsalysin. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risks associated with clinical development, including the risk that enrollment will not be completed on the expected timeline, the results of the Phase 2b study will not be available when expected and risks that the results of the Phase 2b study will not replicate the results of the completed Phase 2a study of topsalysin for the treatment of localized low to intermediate risk prostate cancer or the study endpoint[s] will not be achieved, and other risks and uncertainties identified by Sophiris in its public securities filings with the SEC. All forward-looking statements are based on Sophiris' current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Sophiris Bio Inc.