IRVINE, Calif., May 3 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., (NASDAQ:SPPI) today announced that the Therapeutic Product Directorate of Health Canada has issued a No Objection Letter to Spectrum's Clinical Trial Application. This action authorizes the initiation of investigational clinical trials for ozarelix in Benign Prostate Hypertrophy (BPH), as part of a multinational development program in this indication. Advancement into pivotal registration trials is anticipated in late 2007.
"We expect to begin Phase 3 testing with ozarelix in patients with BPH later this year, and the opportunity to conduct trials with ozarelix at select sites in both Canada and the U.S. will enable us to enroll and begin dosing patients quickly," stated Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum Pharmaceuticals. "Adding Canadian trial sites will allow additional clinicians to learn more about ozarelix and to experience firsthand the potential benefits for the drug in patients suffering from BPH."
In late 2006, Spectrum reported highly statistically significant results in favor of ozarelix from a double-blinded, randomized, placebo-controlled, multi-center, European dose ranging study of ozarelix in men (N=144) with 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 in patients suffering from BPH has just completed enrollment. The data from this trial is 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.
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 that 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.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology 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 reduced-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 our website at www.spectrumpharm.com.
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, our team's ability to identify promising drugs and move these drugs through development and toward commercialization, the initiation of a phase 3 trial in 2007, that the opportunity to conduct trials with ozarelix at select sites in both Canada and the U.S. will enable us to enroll and begin dosing patients quickly, that adding Canadian trial sites will allow additional clinicians to learn more about ozarelix and to experience firsthand the potential benefits for the drug in patients suffering from BPH, that the data from the Phase 2b trial is 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, the safety and efficacy of ozarelix, the potential indications for 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 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 revenues, 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 COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath SVP & Chief Business Officer Porter Novelli Life Sciences 619-849-6007 Paul Arndt Manager, Investor Relations 949-788-6700
Source: Spectrum Pharmaceuticals, Inc.
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