Spectrum completes Phase II trial for ozarelix

The primary endpoint of the study was the change in International Prostate Symptom Score (IPSS), the standard method of assessing benign prostatic hypertrophy (BPH) symptoms. Secondary endpoints included measurements in peak urine flow (Qmax), erectile function, quality of life measures as well as safety and tolerability.

In the intent-to-treat population population, ozarelix demonstrated a numerical improvement in peak urine flow (2.5mL/sec) compared to placebo (1.3mL/sec) at 12 weeks, but did not reach statistical significance (p=0.41). The improvement in IPSS at 12 weeks was 4.4 in placebo group and 2.9 in the ozarelix group, and did not reach statistical significance (p=0.37).

In the per-protocol analysis, ozarelix demonstrated a clinically meaningful improvement in IPSS of six compared to three for placebo. This improvement in IPSS was observed as early as eight weeks, approached statistical significance (p=0.09) and the effect was observed out to 36 weeks. Ozarelix demonstrated a numerical improvement in peak urine flow (1.6mL/sec) as early as four weeks, compared to no change in placebo (0.0mL/sec), (p=0.14), although this difference was not consistently seen at later time points. Based on these results, the company is planning to submit to the FDA a protocol for the next study of ozarelix in BPH.

Rajesh Shrotriya, chairman, president and CEO of Spectrum, said: “We believe that, while the results of this study are not as robust as seen in the previous study, the data indicate clinically meaningful activity in BPH. The information learned will be incorporated into the protocol design of future studies. This was one of the main purposes of performing this trial.”