Spectrum Pharmaceuticals, Inc. has achieved complete enrolment for a phase II trial of ozarelix in hormone dependent prostate cancer ahead of schedule by more than four months. The multi- centre phase II trial is designed to evaluate the effects of ozarelix on hormonal levels, in particular testosterone, as well as objective anti-tumour effects. The open label trial involving 48 patients is being conducted in Europe with the collaboration of AEterna Zentaris our licensor of ozarelix.
"We are very pleased that patient enrolment for this phase II trial of ozarelix was completed well ahead of our planned schedule and without reports of allergic reactions so far, a common side effect of other drugs in this class," stated Rajesh C. Shrotriya, chairman, CEO and president. “With enrolment now complete, we plan on reporting full results in early 2006 and plan to submit abstracts of this data to several significant scientific meetings in 2006," he added.
Ozarelix is a fourth generation LHRH (Luteinizing Hormone Releasing Hormone), also known as GnRH (Gonadotropin Releasing Hormone), antagonist. LHRH antagonists have the potential to treat hormone-dependent cancers as well as benign proliferative disorders such as benign prostatic hypertrophy and endometriosis. More information on ozarelix can be found in our annual report on Form 10-K filed with the Securities and Exchange Commission.