"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
All 18 patients enrolled completed the study. Biopsy data at six months following treatment showed that:
"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.
The Phase 2a proof of concept study was a single-center, open-label study at
Webcast scheduled for today at
The Sophiris management team will host a conference call and webcast today,
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.
About Localized Prostate Cancer
Prostate cancer is the second most common form of cancer in men in the US with an estimated 220,800 new cases in 2015. Approximately 80 percent of patients in the US are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence, and rectal toxicity.
Topsalysin for the Targeted Treatment of Localized Prostate Cancer
Topsalysin (PRX302) has the potential to provide a focal targeted therapy for the ablation of localized prostate cancer while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in mapping previously obtained mpMRI images with real-time three-dimensional ultrasound images enables physicians to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.
Topsalysin, an inactivated pore-forming protein, was engineered to be activated only by enzymatically-active PSA, which is present only in prostate tissue. The targeted focal treatment of prostate cancer is in line with current treatments for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ as possible.
Certain statements included in this press release may be considered forward-looking, including expectations about the potential use of topsalysin for the ablation or focal treatment of prostate cancer tumors, expectations that the Company will able to use data from the proof of concept study to develop more effective delivery and dosing protocols for future clinical trials and implications that the Company will be able to continue to advance the 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, risk associated with clinical trial development, including the risks that clinical data from a subset of patients may not be predicative of clinical data observed in subsequent patients or in subsequent clinical trials of the same drug candidate and other risks associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective, and risks relating to obtaining sufficient capital to enable the Company to continue to operate as a going concern and continue to advance clinical development of topsalysin. 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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sophiris-bio-reports-successful-results-from-completed-phase-2a-study-of-topsalysin-in-localized-prostate-cancer-300282594.html
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