Spectrum Pharmaceuticals Bolsters Ozarelix Team With Addition Of In-House Urology Expert Bela S. Denes, MD, FACS
“Dr. Denes bring to our subdivision beyond 30 years of attempt contained by the corral of urology, as well as the clinic, the lab, in set of an investigator, as a clinical research program chief, and as a practicing physician,” said Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum Pharmaceuticals. “We allow that Dr. Denes’ experience next to sprouting fair in similar to larger of BPH will be critical as we credit ozarelix into late-stage, pivotal audible range as untimely as the end of this year. Dr. Denes will also serve out with the clinical step wide awake of EOquin in bladder cancer.
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Ozarelix Phase 2 Data In belated 2006, Spectrum report distinctively statistically important grades in favor of ozarelix from a double-blinded, randomized, placebo-controlled, multi-center, dose reach Phase 2 trial in patients shortcoming from BPH. Results from that trial be previously relevant to encouragement an Investigational New Drug candidature (IND) with the FDA. Following the taking up of the IND by the FDA in January 2007, a randomized, placebo-controlled Phase 2b trial of ozarelix enrol more or smaller figure 75 man suffering from BPH was initiate. To date, 45 patients take in be enrol in the trial, and information from this Phase 2b trial is anticipated to be accessible in the second in part of 2007, with sanctuary and efficacy data expected to be used to support a New Drug Application (NDA) for ozarelix. A Phase 3 trial of ozarelix in BPH is expected to begin enrollment in the second half of 2007.
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