Sophiris Bio Announces Complete Enrollment in Phase 2b Topsalysin Study of Localized Prostate Cancer
"I am delighted that Sophiris has completed enrollment into its multi-center Phase 2b study. My thanks to the men and my colleagues in each clinical trial center for recognizing the potential of topsalysin to focally treat localized, clinically significant prostate cancer with a minimally invasive, targeted, short duration procedure," said Professor
About the Phase 2b Study
The Phase 2b study is a multi-center, open-label, clinical study evaluating the safety and efficacy of targeted intraprostatic administration of topsalysin for the treatment of histologically proven, clinically significant, localized prostate cancer. The study utilizes previously obtained MRI images of each patient's prostate co-registered to real time 3D ultrasound to target the delivery of topsalysin directly into and around a pre-identified clinically significant tumor. The Company expects biopsy data from all patients dosed with the first administration of topsalysin to be available in the first half of 2018.
Importantly, the Phase 2b study includes an option to re-treat patients with a second dose of topsalysin, with an additional targeted biopsy to occur six months following the second dose. In order to be eligible for a second dose, the patient cannot have experienced a clinically significant adverse event attributable to topsalysin or the dosing procedure from the first dose and the patient will need to have had a clinical response from the first dose but still have the presence of a clinically significant lesion area. Patients who have a complete response to the first dose will not receive a second dose. The Company expects to have final biopsy data on all patients who receive a second dose in the fourth quarter of 2018.
About Localized Prostate Cancer
Prostate cancer is the second most common form of cancer in men in the US with an estimated 161,000 new cases in 2017. 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 (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 of the Chair of Urology, Imperial College London & Imperial College Healthcare NHS Trust, 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
Chief Financial Officer
Corporate Communications Contact: