SAN DIEGO, CA, USA & VANCOUVER, Canada I September 2, 2014 I Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of the symptoms of benign prostatic hyperplasia (BPH, enlarged prostate) and for the treatment of localized prostate cancer, today announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH.
The PLUS-1 trial is an international, multi-center, randomized, double-blind and vehicle-controlled Phase 3 study that will assess the safety and efficacy of a single intraprostatic administration of PRX302 (0.6 µg/g prostate) for the treatment of BPH. The primary endpoint is the International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks. Secondary endpoints include Qmax (maximum urine flow) change from baseline over 52 weeks.
“We reached our targeted enrollment in this first of our Phase 3 studies on schedule,” stated Randall Woods, president and chief executive officer of Sophiris. “We are on track to complete an administrative interim analysis around the end of 2014. The complete data analysis is expected to be available in the second half of 2015.”
BPH is an enlargement of the prostate gland, often resulting in a constricted or partially blocked urethra that can lead to frequent and difficult urination, discomfort, and other complications with urinating. It is estimated that more than five million men in the United States alone are bothered by symptoms of BPH. Current oral drugs for BPH, which are taken daily, often lack sustainable efficacy and may be associated with undesirable side effects including sexual dysfunction. More aggressive treatment options include invasive surgical procedures, which may also cause sexual dysfunction.
About Sophiris Bio
Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of the symptoms of BPH and treatment of localized prostate cancer. 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 prostate cancer in the second half of 2014. For more information, please visit www.sophiris.com.
SOURCE: Sophiris Bio
Post Views: 40
SAN DIEGO, CA, USA & VANCOUVER, Canada I September 2, 2014 I Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of the symptoms of benign prostatic hyperplasia (BPH, enlarged prostate) and for the treatment of localized prostate cancer, today announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH.
The PLUS-1 trial is an international, multi-center, randomized, double-blind and vehicle-controlled Phase 3 study that will assess the safety and efficacy of a single intraprostatic administration of PRX302 (0.6 µg/g prostate) for the treatment of BPH. The primary endpoint is the International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks. Secondary endpoints include Qmax (maximum urine flow) change from baseline over 52 weeks.
“We reached our targeted enrollment in this first of our Phase 3 studies on schedule,” stated Randall Woods, president and chief executive officer of Sophiris. “We are on track to complete an administrative interim analysis around the end of 2014. The complete data analysis is expected to be available in the second half of 2015.”
BPH is an enlargement of the prostate gland, often resulting in a constricted or partially blocked urethra that can lead to frequent and difficult urination, discomfort, and other complications with urinating. It is estimated that more than five million men in the United States alone are bothered by symptoms of BPH. Current oral drugs for BPH, which are taken daily, often lack sustainable efficacy and may be associated with undesirable side effects including sexual dysfunction. More aggressive treatment options include invasive surgical procedures, which may also cause sexual dysfunction.
About Sophiris Bio
Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of the symptoms of BPH and treatment of localized prostate cancer. 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 prostate cancer in the second half of 2014. For more information, please visit www.sophiris.com.
SOURCE: Sophiris Bio
Post Views: 40
