OPK-88004 has the ability to serve as an antagonist to androgen receptors in the prostate, resulting in decreased prostate specific antigen (
OPKO is currently conducting a Phase 2 clinical trial that evaluates the effect of 15mg and 25mg doses of OPK-88004 on prostate volume in patients with Benign Prostatic Hyperplasia. In reviewing the blinded data, it has been noticed that to measure one of the study’s primary endpoints (decreases in prostate volume), the trans-rectal ultrasound method proved to be too imprecise to reliably determine the drug effect. Also, although most of the laboratory changes were consistent with this class of drugs, increases in liver enzymes were observed in several men at these higher doses. The increases were transient in patients that completed the trial and returned to normal once the drug was withdrawn. Importantly, no increases in liver enzymes were observed in a previous large Phase 2 study of 420 men taking lower doses of OPK-88004 (1mg and 5mg). OPKO plans to suspend the current trial but continue to analyze data relating to the other primary endpoint, the effect of OPK-88004 on serum
OPKO is planning additional exploratory Phase 2 clinical studies to assess the feasibility of OPK-88004 in other indications. One of the trials is designed to study the safety and efficacy of OPK-88004 in prostate cancer patients treated with Androgen Deprivation Therapy (ADT). ADT results in the reduction of testosterone to castration levels in men with prostate cancer. However, ADT is associated with side effects such as decreased LBM, physical function, bone quality and increases in body fat, frailty and hot flashes. The diminished quality of life results in approximately one-third of men treated with ADT stopping treatment within six months of initiation. OPKO’s trial data in aging men indicate that OPK-88004 increases LBM, decreases fat and increases physical function. Because OPK-88004 decreases
Because of OPK-88004’s significant increase of muscle mass (LBM) and strength, and because of OPKO’s strong interest in the therapy of chronic kidney disease (CKD) patients, another Phase 2 trial is planned to treat kidney dialysis patients who have low testosterone levels and commonly suffer from muscle weakness and general frailty. Approximately 500,000 CKD patients are on dialysis therapy in the U.S.
About OPKO Health, Inc.
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This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements about expectations for the SARM and our ability to develop it for ADT and other indications, as well as other non-historical statements about our expectations, beliefs or intentions. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the
Source: OPKO Health, Inc.