Spectrum prostate drug fails in mid-stage study
NEW YORK, April 22 (Reuters) - Spectrum Pharmaceuticals Inc (SPPI.O) said on Tuesday its experimental treatment for enlarged prostate glands failed to meet its primary goal in a study and that violations of the trial's design were seen at several study sites.
The company said its drug, ozarelix, demonstrated a clinically meaningful improvement, as judged by the International Prostate Symptom Score (IPSS), the standard method of assessing BPH symptoms. But the improvement was not statistically significant, the company said in a release.
"The company's monitoring of the conduct of the study revealed major protocol violations at four of the fifteen sites," the company said.
It said violations in the mid-stage trial include inaccurate diagnosis, simultaneous use of other drugs for enlarged prostates and patient participation in multiple trials at the same time. One of the sites was closed early due to irregularities in data collection and was reported to the FDA, Spectrum said.
Despite the drug's failure to achieve statistically significant improvement in symptoms, Spectrum said the drug showed sufficient activity to warrant continued development. (Reporting by Ransdell Pierson; Editing by Andre Grenon)
