IRVINE, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the presentation of Phase 2 data of Ozarelix in prostate cancer at the 28th Congress of the Societe Internationale d’Urologie in Cape Town, South Africa.
The presentation, “Phase 2 dose finding study of Ozarelix, an LHRH antagonist, in patients with inoperable prostate cancer,” (presentation #PD01.04) will be given by Professor Frans M.J. Debruyne, Chairman of the Department of Urology, University Medical Center in Nijmegen, The Netherlands, and Chairman of the European Urology Association. The study, which met its primary endpoint, demonstrated that Ozarelix was safe and effective and provided a required continuous testosterone suppression ( < 0.5 ng/mL) between day 8 and day 85 at an intramuscular dose of 130 mg given every four weeks. The secondary endpoint, a 50 percent reduction of prostate specific antigen (PSA) was, with respect to baseline, also achieved in all patients. The study was an open-label, randomized-controlled, multi-center study.
“We are encouraged by the safety and efficacy results demonstrated in the trial,” stated Raj C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. “Ozarelix demonstrates the depth of our pipeline behind our other three late-stage opportunities that include Satraplatin, LFA and EOquin.”
About Ozarelix and the Development Alliance with AEterna Zentaris
Ozarelix is a fourth generation Lutenizing 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. Earlier this year, Spectrum announced top-line data from the first Phase 2 study in patients suffering from hormone-dependent prostate cancer. In addition, the company announced positive Phase 2 data in patients with BPH.
About Prostate Cancer
Prostate cancer is the second leading cause of cancer-related deaths in men. According to the American Cancer Society, approximately 234,460 new cases and 27,350 deaths will occur in the U.S. during 2006.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is opportunistically acquiring and advancing 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 www.spectrumpharm.com.
Forward-Looking Statements
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 and develop its portfolio of drug candidates, the Company’s promising pipeline 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.
Contacts: Susan Neath Media Porter Novelli Life Sciences 619-849-6007 Rajesh C. Shrotriya, M.D. Russell Skibsted Chairman, President & CEO SVP & Chief Business Officer Spectrum Pharmaceuticals Spectrum Pharmaceuticals 949-743-9295 949-743-9234
Spectrum Pharmaceuticals, Inc.
CONTACT: Susan Neath of Porter Novelli Life Sciences, +1-619-849-6007,Media Relations for Spectrum Pharmaceuticals, Inc.; or Rajesh C. Shrotriya,M.D., Chairman, President & CEO, +1-949-743-9295, or Russell Skibsted, SVP& Chief Business Officer, +1-949-743-9234, both of SpectrumPharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
