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Home » SPECTRUM ANNOUNCES POSITIVE DATA FROM BPH STUDY
SPECTRUM ANNOUNCES POSITIVE DATA FROM BPH STUDY
October 4, 2006
Spectrum Pharmaceuticals has announced that its double-blinded, randomized, placebo-controlled, multicenter, dose-ranging Phase II trial with ozarelix in patients suffering from benign prostatic hypertrophy (BPH) met the primary endpoint. The results were highly statistically significant in improving clinical symptoms of BPH as measured by the International Prostate Symptom Score (IPSS), the standard method of assessing BPH symptoms and the primary endpoint of the study. The trial was conducted in Europe in collaboration with Spectrum Pharmaceutical's partner AEterna Zentaris.
In this study, 144 patients with symptomatic moderate to severe BPH were randomized to placebo or different doses of ozarelix given intramuscularly at day one and day 15.
While the primary efficacy endpoint was achieved at all dosage regimens, the best results were obtained with the 15-mg dose of ozarelix, in terms of decrease of the IPSS score. Using the 15-mg dose, the observed mean decrease in the IPSS score at weeks 12, 20 and 28 was -8.6, -9.4 and -8.7, respectively (47 percent decrease from baseline). This improvement in the IPSS represents a highly statistically significant difference versus baseline as well as versus placebo. Furthermore, this long-lasting effect, which was still present at the end of the 28-week observation period, was seen at all dosage regimens.
Ozarelix also achieved improved secondary endpoint parameters such as urine flow, residual urinary volume and quality of life. The results of the trial demonstrated the excellent safety profile of ozarelix in all doses, and patients had no drug-related serious side effects.
KEYWORDS Drug Pipeline Alert
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