Sophiris Bio Receives Positive Feedback from European Medicines Agency Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design
"Based on the safety profile of topsalysin in 451 patients in our clinical development program along with the efficacy seen in our Phase 2 studies in localized prostate cancer, we approached the EMA with our proposed study design for a single Phase 3 trial to support registration in
The Phase 3 study design, agreed upon by the EMA, will enroll patients with a confirmed diagnosis of intermediate risk disease. Approximately 700 men who meet the eligibility criteria will be equally randomized to receive a single administration of either topsalysin or placebo. The primary endpoint for the study will be the proportion of patients at 12 months who have failed treatment, defined as histological progression of disease resulting in the need for alternative intervention, per an independent central adjudication panel.
Webcast scheduled for today at 9:30 a.m. Eastern Time
The Sophiris management team will host a conference call and webcast today, June 19, at 9:30 a.m. Eastern Time to review the key details of the proposed Phase 3 clinical trial design and to address the potential commercial opportunity for topsalysin, along with Professor Hashim Ahmed, Faculty of
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
Topsalysin (PRX302), an innovative, "First-in-Class" transmembrane pore-forming protein, was genetically modified to be activated only by enzymatically-active
Topsalysin has the potential to provide a targeted focal therapy for the ablation of localized prostate cancer lesions 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 software to co-register previously obtained mpMRI images with real-time three-dimensional ultrasound images enables urologists 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.
Certain statements included in this press release may be considered forward-looking, including the quote from the CEO and expectations about further development of topsalysin (PRX302), plans relating to execution of a Phase 3 clinical trial in localized prostate cancer, Sophiris' liquidity or capital requirements and the ability to obtain additional financing or execute other strategic alternatives. 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, risks that the Company will be able to fund future clinical trials or enter into a strategic transaction, risks about the Company's ability to continue as a going concern and other risks and uncertainties identified by Sophiris in its public securities filings with the Securities and Exchange Commission. 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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Company Contact: Peter Slover, Chief Financial Officer, (858) 777-1760; Corporate Communications and Media Contact: Jason Spark, Canale Communications, (619) 849-6005, firstname.lastname@example.org