Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of urological diseases. PRX302 is in Phase 3 clinical development for the treatment of the symptoms of BPH and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris plans to initiate a Phase 2 proof of concept study of PRX302 for the treatment of localized low to intermediate risk prostate cancer during the first half of 2015.
Initially most men with BPH will be treated with oral medications but many will discontinue drug therapy due to inadequate response and/or side effects, which include sexual dysfunction and cardiovascular side effects. They may then undergo a surgical procedure which can be painful and have potential long-term sexual side effects, or may stop treatment altogether. PRX302 is designed to be a convenient treatment that is safer and less invasive than surgery and more effective and better tolerated than currently approved pharmaceutical therapies.
In our Phase 2b clinical trial, we saw significant symptom relief from a single treatment of PRX302 that was sustained throughout the follow-up period of 12 months, and there were no drug-related erectile dysfunction or cardiovascular side effects reported. In 2009, we licensed exclusive rights to PRX302 from UVIC Industry Partnerships Inc. and The Johns Hopkins University, for the treatment of symptoms of BPH. In April, 2010, we entered into an exclusive license agreement with Kissei Pharmaceutical Co., Ltd., for the development and commercialization of PRX302 in Japan for the treatment of symptoms of BPH, prostate cancer, prostatitis, or other diseases of the prostate. Sophiris has completed enrollment in a Phase III clinical trial (PLUS 1) using PRX302 for the treatment of the symptoms of BPH. For more information please see study NCT1966614 on www.clinicaltrials.gov.