Healthcare Industry News: GPC Biotech
News Release - March 22, 2007
Satraplatin Phase 3 SPARC Trial - Additional Data Presented at European Association of Urology Congress* Patients Treated With Satraplatin Demonstrated Statistically Significant Improvement in Pain Response and PSA Response Rates
* $4M Milestone Payment to Spectrum Pharmaceuticals to Trigger Following NDA Acceptance by FDA
IRVINE, Calif., March 22 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI ) today announced that additional data from the double-blind, randomized satraplatin Phase 3 trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer) were presented today at the 22nd Annual European Association of Urology Congress in Berlin, Germany. The SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer (HRPC) who have failed prior chemotherapy.
"The additional data reconfirm previous data we have seen from the trial, showing that satraplatin provides both pain relief and improvement of progression-free survival for prostate cancer patients that have failed all prior treatments. If approved, satraplatin will be the only drug for hormone refractory prostate cancer patients in the second-line setting, and we believe that the convenience of oral dosing and favorable tolerability will also offer an improvement in quality of life," stated Luigi Lenaz, M.D., and Chief Scientific Officer of Spectrum Pharmaceuticals. "We look forward to the FDA acceptance of the NDA for satraplatin next month and the availability of the full data sets from the Phase 3 SPARC trial at the American Society of Clinical Oncology Annual Meeting in June."
Pain Response Rate and Analgesic Score
Data presented today from the SPARC study showed that pain response rates for patients treated with satraplatin were statistically significantly superior compared to the pain response rates for those patients in the comparator arm. Pain response rates were 24.2 percent for the satraplatin plus prednisone arm compared with 13.8 percent for the prednisone arm (p<0.005).
Pain response was assessed by patients using a weekly present pain intensity (PPI) and analgesic score. The PPI score was defined according to the McGill-Melzack questionnaire with 0 = no pain, 1 = mild pain, 2 = discomforting pain, 3 = distressing pain, 4 = horrible pain and 5 = excruciating pain. The criteria for pain response are a greater than or equal to two-point reduction in the patients' weekly PPI score from baseline and maintenance of the two-point reduction for at least five consecutive weeks in the setting of a stable or decreasing weekly analgesic score compared to baseline. Patients were evaluable for pain response if their baseline PPI score was greater than or equal to one and had completed four consecutive weekly assessments of PPI and analgesic scores during the study treatment.
Prostate Specific Antigen Response Rate
Data from the SPARC trial also showed that the prostate specific antigen (PSA) response rate for patients treated with satraplatin was significantly improved compared to the PSA response rate for those patients in the prednisone arm. PSA response rates were 25.4 percent for the satraplatin plus prednisone arm compared with 12.4 percent (p<0.001) for the prednisone arm.
PSA response was analyzed using the widely adopted Bubley criteria of a decrease of PSA level by greater than or equal to 50 percent from baseline, with confirmation at least four weeks later.
The pain and PSA response analyses, in addition to the previously presented PFS data, further define satraplatin's clinical profile as a potential second-line treatment option in metastatic HRPC.
In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival. Overall survival data are expected to be available later this year.
Common Adverse Events & Side Effect Profile
Safety findings were consistent with previous clinical studies involving satraplatin. The most common adverse reactions consisted of myelosuppression (bone marrow functions): Twenty-one percent of patients in the satraplatin arm experienced grade 3 or 4 thrombocytopenia; 14 percent had leucopenia and 21 percent had neutropenia. Eight percent of patients in the satraplatin arm experienced grade 3 or 4 gastrointestinal toxicities, including nausea (1.3%), vomiting (1.6%), diarrhea (2.1%) and constipation (2.1%). Five percent or less of patients in the satraplatin arm experienced grade 3 or 4 fatigue, grade 3 or 4 infections and pulmonary/respiratory grade 3 or 4 toxicities.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. According to the American Cancer Society, approximately 219,000 men in the U.S. are expected to be diagnosed and over 27,000 men are expected to die from the disease in 2007. In the European Union, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones -- or "hormone-refractory" -- and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for hormone-refractory prostate cancer. However, it is not a cure, and so this is creating a need for effective therapeutic options for these patients once they have progressed.
Satraplatin, a fourth-generation, oral investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an oral compound and is given as capsules that patients can take at home.
In addition to HRPC, satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.
In 2002, Spectrum licensed the global rights to GPC Biotech (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB). GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. The NDA for satraplatin was filed with the FDA in February 2007. The FDA's acceptance of the NDA will trigger a $4 million milestone payment to Spectrum. GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
About Spectrum Pharmaceuticals
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 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 safety and efficacy of satraplatin, that the convenience of oral dosing and favorable tolerability of satraplatin will also offer an improvement in quality of life, that the FDA will accept the NDA for satraplatin next month and the full data sets from the Phase 3 SPARC trial will be presented at the American Society of Clinical Oncology Annual Meeting in June, that trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types will be initiated 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.
Source: Spectrum Pharmaceuticals
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