Spectrum Pharmaceuticals Announces FDA's Acceptance of Ozarelix IND and Approval of Phase 2b Protocol in BPH (Benign Prostate Hypertrophy)
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- Published on Thursday, 04 January 2007 02:00
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IRVINE, CA, USA | Jan 03, 2007 | Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for ozarelix in Benign Prostate Hypertrophy (BPH) and that the FDA has approved the protocol for the Phase 2b study of ozarelix for the treatment of BPH. Dr. Claus Roehrborn from the UT Southwestern Medical Center at Dallas, Department of Urology, will serve as the lead investigator.
The Phase 2b study is a randomized, placebo-controlled trial of ozarelix involving approximately 100 men suffering from BPH. In this trial, the men will be dosed with 15 mg of ozarelix or placebo on day 1 and day 15 and will be followed for 6 months following dosing. The study will evaluate safety and assess the clinical efficacy of ozarelix as a treatment for BPH. The primary endpoint of the study will be 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, residual urine volume and quality of life. This trial will begin in January 2007 and data from this trial is expected to be available in approximately six months time after the trial is initiated. Safety and efficacy data from this trial will be used to support a New Drug Application (NDA) for ozarelix.
"This trial will enable clinical investigators to familiarize themselves with ozarelix prior to the start of the pivotal Phase 3 trials, which are scheduled to begin in the second half of 2007," stated Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum Pharmaceuticals. "We are very pleased that Dr. Roehrborn, an internationally recognized leader in the diagnosis and treatment of BPH, has agreed to serve as the lead investigator for this and subsequent trials as his knowledge and expertise in BPH will be invaluable."
Earlier this year, 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. Current therapies require the patient to be dosed daily. Using the 15 mg dose, the observed mean decrease in the IPSS score at weeks 12, 20 and 28 were -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<0.001) as well as versus placebo (p<0.0001).
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, leading to inadequate compliance. Medications currently available belong to two classes: alpha blockers (such as FLOMAX(R), CARDURA(R) and HYTRIN(R)) 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) and AVODART(R)), 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 http://www.spectrumpharm.com.
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 the Phase 2b study will begin in January 2007 and data will be available in approximately six months time after the trial is initiated, 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.
 FLOMAX is a registered trademark of Boehringer Ingelheim
 CARDURA is a registered trademark of Pfizer, Inc.
 HYTRIN is a registered trademark of Abbott Laboratories
 PROSCAR is a registered trademark of MERCK & CO., Inc.
 AVODART is a registered trademark of GlaxoSmithKline
Media Raj Shrotriya Russell Skibsted
Susan Neath President & CEO SVP & Chief Business
Porter Novelli Life Spectrum Officer
Sciences Pharmaceuticals Spectrum
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SOURCE Spectrum Pharmaceuticals, Inc.