Healthcare Industry News: GPC Biotech
News Release - May 21, 2007
Additional Satraplatin Efficacy Data From Phase 3 SPARC Trial Presented at Annual Meeting of American Urological Association* Highly Significant Improvement in Median Time-to-Pain Progression = 66.1 Weeks for Satraplatin vs. 22.3 Weeks for Placebo
IRVINE, Calif., May 21 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI ) today announced the presentation of additional satraplatin data from the double-blind, randomized, placebo-controlled Phase 3 registrational SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The data were presented today at the Annual Meeting of the American Urological Association (AUA) in Anaheim, California. 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 NDA for satraplatin is currently under priority review by the U.S. FDA, with an Oncology Drug Advisory Committee (ODAC) review on July 24, 2007, and a Prescription Drug User Fee Act action date of August 15, 2007.
"Patients with metastatic hormone-refractory prostate cancer frequently suffer from substantial pain associated with bone metastases. Thus, pain control for these patients constitutes a major challenge and is an important goal when caring for them," said Oliver Sartor, M.D., Lank Center for Genitourinary Oncology, Dana Farber Cancer Institute, Associate Professor at Harvard Medical School, Boston, MA, and principal investigator of the SPARC trial, who presented the satraplatin data today. "It is very encouraging to see that the SPARC trial results show that treatment with satraplatin results in a statistically significant improvement in time to pain progression."
"The data presented today show a significant improvement in pain response and time to pain progression, thus supporting the activity of satraplatin in this refractory patient population and showing that the drug can favorably affect the quality of life of these patients. We have confidence in the clinical and statistical robustness of the study data," said Luigi Lenaz, M.D., and Chief Scientific Officer of Spectrum Pharmaceuticals. "We remain optimistic regarding the potential for a favorable outcome from the FDA."
Time to Pain Progression and Pain Response
The data presented today showed that the median time to pain progression was 66.1 weeks for the satraplatin arm compared with 22.3 weeks for the placebo arm. The hazard ratio was 0.64 (95% CI: 0.51-0.79, p<0.001). These results were consistent across subsets, including patients treated with prior TaxotereŽ (docetaxel). All pain progression events were adjudicated by a blinded independent review committee. Complementing the time to pain progression data, pain response rates were 24.2 percent for the satraplatin plus prednisone arm (N=351) compared with 13.8 percent for the placebo arm (N=181) (p=0.005). Pain response rates for patients treated with prior Taxotere were 25.7 percent for the satraplatin arm compared with 13.1 percent for control (p<0.015). All of the findings presented today continue to build on the data previously presented from the SPARC trial.
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, 3 = distressing pain, 1 = mild pain, 4 = horrible pain, and 2 = discomforting pain, 5 = excruciating pain.The criteria for pain response are a greater than or equal to 2 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.
Safety and Common Adverse Reactions
Safety findings in the SPARC trial were consistent with previous clinical studies involving satraplatin. The most common adverse reactions consisted of myelosuppression (bone marrow functions): 21 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 percent), vomiting (1.6 percent), diarrhea (2.1 percent) and constipation (2.1 percent). 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 or enter long-term remission. 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 may 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 or relapsed.
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 hormone refractory prostate cancer, 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 chemotherapy 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. 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.
Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC.
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 risk-reduced 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, the activity of satraplatin in hormone refractory prostate cancer and that satraplatin can favorably affect the quality of life of these patients, a favorable outcome from the FDA for satraplatin, that trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer chemotherapy and in a number of cancer types are underway or planned 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 our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, 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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