Healthcare Tips

Spectrum Pharmaceuticals Initiates Phase 2b Trial For Ozarelix In Patients With Benign Prostate Hypertrophy

September 11, 2017

Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that the first patient has been dosed in the company's Phase 2b study of ozarelix in the U.S. in patients with benign prostate hypertrophy (BPH). The trial will be conducted in accordance with the protocol recently accepted by the U.S. Food and Drug Administration (FDA).

The Phase 2b study is a randomized, double blind, placebo controlled trial of ozarelix enrolling approximately 100 men suffering from BPH. In this trial, patients will be dosed with 15 mg of ozarelix or placebo on day 1 and day 15 and will then be followed for six months. The study will evaluate safety and assess the 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. Data from the study will be used to support a New Drug Application (NDA) for ozarelix with the FDA for the treatment of BPH. Dr. Claus Roehrborn, Professor and Chairman at the UT Southwestern Medical Center at Dallas, Department of Urology, will be the lead investigator. Dr. Roehrborn is an internationally recognized leader in the diagnosis and treatment of BPH. "We are pleased to meet our objective of initiating the Phase 2b trial of ozarelix this month, and we are on track to initiate a Phase 3 trial in the second half of 2007 to evaluate long-term efficacy and safety of ozarelix courses given at six-month intervals," said Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum Pharmaceuticals. "Based on results from our earlier Phase 2 trial in which clinical efficacy was maintained for 6 months following dosing, ozarelix may represent an important advance in the treatment of BPH for the more than 28 million American men who are currently suffering from this disease. Currently marketed therapies are limited by their relatively mild improvement in BPH symptoms, their bothersome sexual side effects and by the fact that compliance can be an issue because the treatments require daily dosing." In 2006, Spectrum reported results from a double-blinded, randomized, placebo-controlled, multi-center, dose ranging Phase 2 trial with ozarelix in patients suffering from BPH. While the primary efficacy endpoint was achieved at all dosage regimens in this trial and ozarelix was well tolerated, the best results were obtained with the 15 mg dose, in terms of improvement in the IPSS score. Importantly, with this dosage regimen, where the patient is dosed on day 1 and day 15, the clinical efficacy was maintained for 6 months. Using the 15 mg dose, the observed mean decrease in the IPSS score following placebo run-in at weeks 12, 20 and 28 was -8.6, -9.4 and -8.7, respectively (mean: 47% decrease from baseline). This improvement in the IPSS represented a highly statistically significant and clinically meaningful difference versus baseline (p About Ozarelix and Development Alliance with AEterna Zentaris

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 recently been licensed to Nippon Kayaku, a key player in the Japanese oncology market.

Spectrum is developing ozarelix for benign prostatic hypertrophy (BPH), hormone-dependent prostate cancer and other indications.

About Benign Prostatic Hypertrophy

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, potentially 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.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit spectrumpharm.

Forward-looking statement

This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, that ozarelix may represent an important advance in the treatment of BPH, that we will initiate pivotal Phase 3 trials of ozarelix in BPH in the second half of 2007, the safety and efficacy of ozarelix and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that past results may not be indicative of future results, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of significant revenues, our limited human and financial resources, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

[1] FLOMAX is a registered trademark of Boehringer Ingelheim

[2] CARDURA is a registered trademark of Pfizer, Inc.

[3] HYTRIN is a registered trademark of Abbott Laboratories

[4] PROSCAR is a registered trademark of MERCK & CO., Inc.

[5] AVODART is a registered trademark of GlaxoSmithKline

Spectrum Pharmaceuticals, Inc.

View drug information on FLOMAX; Proscar.