Healthcare Industry News: Aeterna Zentaris
News Release - August 2, 2006
Spectrum Pharmaceuticals Announces Phase 2 Data for Ozarelix in Hormone-Dependent Prostate CancerIRVINE, Calif., Aug. 2 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI ) today announced data from its Phase 2 trial with ozarelix for patients suffering from hormone-dependent prostate cancer.
In this study, ozarelix was administered intramuscularly in 65, 100 or 130 mg according to different dosing schedules and repeated for 3 cycles of 28 days. The total dose by patient during the study ranged from 230 mg to 390 mg. Patients receiving doses of 130 mg per cycle of ozarelix have shown the greatest continuous suppression of testosterone, the primary endpoint, where patients remained suppressed to castration until at least day 85. In patients with continuous testosterone suppression, tumor response as measured by PSA levels, was 97%. Ozarelix was well tolerated at all dosages. Full detailed results from the complete Phase 2 study will be presented at the upcoming Societe Internationale d'Urologie (SIU) meeting to be held in Cape Town, South Africa on November 12-16, 2006.
This trial is an open-label Phase 2 trial evaluating different intramuscular dosage regimens of the Luteinizing Hormone Releasing Hormone (LHRH) antagonist, ozarelix, to assess its safety and efficacy. This study's primary endpoint is to define the most tolerable dosage regimen of ozarelix that would ensure continuous suppression of testosterone at castration levels (< 0.5 ng/mL) for a three month test period. Ozarelix's effect on tumor responses are determined by assessing serum PSA response, determined as a 50% or greater reduction of serum PSA levels, compared to baseline. The trial is being conducted in Europe in collaboration with Spectrum's partner, Aeterna Zentaris (Nasdaq: AEZS ; Toronto: AEZ ), and has enrolled 64 patients. An additional study, which will evaluate an additional 32 patients, has been initiated at other European clinical sites.
"We are encouraged by the safety and efficacy results demonstrated in the trial thus far," 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 Luteinizing Hormone Releasing Hormone LHRH antagonist administered as a depot formulation that is being studied as a treatment for hormone-dependent prostate cancer. 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 share with Aeterna Zentaris upfront and milestone payments, royalties or profits from sales of the product in Japan.
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 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 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.
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, ozarelix's ability to treat hormone-dependent prostate cancer, 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.
Source: Spectrum Pharmaceuticals
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