Date: 2017-11-27
Type of
information: Recruitment of the first patient
phase: 2b
Announcement: recruitment of the first patient
Company: Opko Health (USA - Fl)
Product: OPK88004
Action
mechanism:
- selective androgen receptor modulator (SARM). Interest in evaluating OPK88004 as a treatment for BPH is based on data from a 12 week study of 350 men who showed significantly decreased fat mass, increased lean body mass, and increased muscle strength without significantly changing PSA levels in the overall population, while reducing PSA levels in men with elevated PSA levels. The selective and antagonistic properties of OPK88004 appear to be well suited to potentially reduce prostate hypertrophy in BPH subjects, while providing anabolic benefits such as increased lean body mass and muscle strength. In previously conducted dog studies, treatment with OPK88004 for 6 months decreased prostate weight by up to 75%, demonstrating the potent antagonistic effects of OPK8004 on androgen receptor activity in the prostate.
Disease: benign prostatic hypertrophy
Therapeutic
area: Urological diseases
Country: USA
Trial
details:
- This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on prostate size and related lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). (NCT03297398)
Latest
news:
- • On November 27, 2017, OPKO Health announced that the company has enrolled the first patient in a Phase 2b dose ranging trial of OPK88004, its orally administered selective androgen receptor modulator (SARM), to treat men with benign prostatic hypertrophy (BPH) or enlarged prostate.
- This trial will enroll approximately 125 men with BPH at 30 sites in the U.S. to identify appropriate doses given over a four month treatment period to reduce prostate size, the primary efficacy endpoint of the study. The study will also assess secondary endpoints, including blood prostate specific antigen (PSA) levels and body composition parameters such as lean body mass and fat mass.
Is
general: Yes
