Sophiris Bio Announces that the First Patient Has Been Dosed in Phase 2b Study of Topsalysin in Patients with Clinically Significant Localized Prostate Cancer
This Phase 2b study will build on the successful Phase 2a proof-of-concept study for the treatment of localized prostate cancer which demonstrated that a targeted intraprostatic administration of topsalysin has the potential to safely ablate prostate tumor cells.
"Topsalysin has the potential to provide a much-needed opportunity to treat the patients who have clinically significant localized prostate cancer in a targeted focal manner, ablate pre-identified lesions and downgrade the patient to non-significant cancer," said Dr.
"We have the potential to provide an efficacious, less invasive treatment option for patients with clinically significant localized prostate cancer," said
About the Phase 2b Study
The study is a multi-center, open-label, Phase 2b study evaluating the safety and efficacy of targeted intraprostatic administration of topsalysin for the treatment of histologically proven, clinically significant, localized prostate cancer. Approximately 40 patients will be enrolled in the study at multiple sites in
Importantly, the Phase 2b study includes an option to re-treat patients with a second dose of topsalysin, with a 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 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. 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" pore-forming protein, was engineered to be activated only by enzymatically-active PSA, which is produced in large quantities exclusively within the prostate of men with prostate cancer. The targeted focal treatment of prostate cancer is in line with current treatment trends for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ and organ function as possible.
Topsalysin 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 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 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
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