Spectrum Completes Target Enrollment In Ozarelix Phase 2b Trial In Benign Prostate Hypertrophy

Armen Hareyan's picture

Prostate Hypertrophy

Spectrum Pharmaceuticals announced that the Company has reached its enrollment target in the Phase 2b trial of ozarelix in patients suffering from benign prostatic hypertrophy (BPH).

"We received FDA approval to initiate the trial in January 2007 and the first patient was enrolled shortly thereafter. Target enrollment was reached in approximately 3 months. The rapid enrollment in this study is certainly indicative of the large unmet medical need for more effective BPH treatments, as well as the high level of interest our investigators have in ozarelix," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "However, enrollment wouldnot have been completed this quickly without the efficiency and effectiveness of our outstanding team here at Spectrum."

The Phase 2b study is a randomized, double blind, placebo controlled trial of ozarelix in men suffering from BPH. In this trial, patients are dosed with 15 mg of ozarelix or placebo on day 1 and day 15 and followed for six months. The study is evaluating the safety and efficacy of ozarelix as a treatment for BPH. The primary endpoint of the study is the improvement of BPH symptoms as measured by the International Prostate Symptom Score (IPSS), the standard method of assessing BPH symptoms. The study will also measure urine flow and quality of life as secondary endpoints.

Data from the Phase 2b trial are expected to be available in the second half of 2007, with safety 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.


In late 2006, Spectrum reported highly statistically significant results in favor of ozarelix from a double-blinded, randomized, placebo-controlled, multi-center, dose ranging Phase 2 trial in patients suffering from BPH. Results from that trial were used to support an Investigational New Drug application (IND) with the FDA. Following the acceptance of the IND by the FDA in January 2007, a randomized, placebo-controlled Phase 2b trial of ozarelix enrolling approximately 75 men suffering from BPH was initiated.

Ozarelix is a fourth generation Luteinizing Hormone Releasing Hormone (LHRH) antagonist administered as an intramuscular injection. In August 2004, Spectrum received an exclusive license from AEterna Zentaris to develop and market ozarelix for all potential indications in North America (including Canada and Mexico) and India.

In addition, Spectrum will receive 50 percent of any upfront and milestone payments, royalties and/or profits from sales of the product in Japan. Japanese rights for all potential oncology indications have been licensed to Nippon Kayaku, a key player in the Japanese oncology market.

Spectrum is developing ozarelix for BPH, hormone-dependent prostate cancer and other indications.

Benign prostatic hypertrophy is a non-cancerous enlargement of the prostate frequently occurring in men over the age of 50. According to the National Institutes of Health, BPH affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70 and it is estimated that there are currently more than 28 million men suffering from BPH in the United States.

The IPSS (also known as AUA symptom index) is a standardized scoring system, which evaluates the seven principal symptoms of BPH. The enlargement can result in the gradual squeezing of the urethra, resulting in increased frequency or difficulty in urinating. Treatment options for BPH include surgery and medications to reduce the amount of tissue and increase the flow of urine. Current treatment options have limited efficacy, leading to inadequate compliance. Medications currently available belong to two classes: alpha blockers (such as FLOMAX(R)[1], CARDURA(R)[2] and HYTRIN(R)[3]) which relax the muscles in the neck of the bladder and in the prostate, but have no direct effect on the prostate growth itself, and alpha reductase inhibitors (such as PROSCAR(R)[4] and AVODART(R)[5]), which can result in some reduction of the prostate size but have a very slow onset of action, and may be associated with impotence and decreased libido.