Healthcare Industry News: Vidaza
News Release - March 22, 2007
Additional Data from Satraplatin SPARC Phase 3 Trial Presented at European Association of Urology CongressPatients treated with Satraplatin Demonstrated Statistically Significant Improvement in Pain Response and PSA Response Rates
* Pain response rates of 24.2 percent for the satraplatin arm compared with 13.8 percent for the placebo arm (p=0.005)
* PSA response rates of 25.4 percent for the satraplatin arm compared with 12.4 percent for the placebo arm (p<0.001)
BERLIN, March 22 (HSMN NewsFeed) -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) and Pharmion Corporation (Nasdaq: PHRM ) today announced additional data from the double-blind, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer) which were presented today at the 22nd Annual European Association of Urology Congress in Berlin, Germany. The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer (HRPC) who have failed prior chemotherapy.
"Second-line chemotherapy for patients with hormone-refractory prostate cancer represents a true unmet medical need and the encouraging satraplatin data suggest that for the first time, we may have a treatment option for these patients with advanced disease," said Professor Fred Witjes, Professor of Urology, Academisch Ziekenhuis, Nijmegen, The Netherlands. "In particular, the very impressive pain and PSA response rates seen in the SPARC study, especially considering the fact that all these patients were progressive after hormones and chemotherapy, further suggest satraplatin's active anti-tumor effect in this patient population."
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 placebo 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 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.
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 placebo arm. PSA response rates were 25.4 percent for the satraplatin plus prednisone arm compared with 12.4 percent for the placebo arm (p<0.001).
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.
Marcel Rozencweig, M.D., chief medical officer and senior vice president, drug development of GPC Biotech said: "Patients with hormone-refractory prostate cancer frequently suffer from terrible pain associated with bone metastases. The satraplatin data presented today continue to build on the progression-free survival data already presented from the SPARC trial."
"We believe the PSA response rate provides important information especially in this challenging second-line context," said Andrew Allen, Pharmion's chief medical officer and executive vice president. "To see this level of response for both pain and PSA is very encouraging and provides important additional insight on the clinical profile of satraplatin in patients with advanced prostate cancer."
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. Pharmion expects to complete the Marketing Authorization Application (MAA) for satraplatin for Europe in the second quarter of 2007. GPC Biotech recently completed the New Drug Application (NDA) submission for satraplatin to the U.S. Food and Drug Administration (FDA).
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. Approximately 219,000 men in the U.S. are expected to be diagnosed with the disease in 2007 and over 27,000 men are expected to die from the disease. 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, an 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 orally bioavailable compound and is given as capsules that patients can take at home.
GPC Biotech and Pharmion have a co-development and license agreement under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
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.
Pharmion is a biopharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. GPC Biotech's lead product candidate -- satraplatin -- has achieved target enrollment in a Phase 3 registrational trial as a second- line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and GPC Biotech has completed the rolling NDA submission process for this compound. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany), and its wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG and Pharmion Corporation, including statements relating to results of the SPARC trial and statements relating to the potential efficacy and safety profile of satraplatin. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. In particular, there can be no guarantee that additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. Furthermore, we cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product. We direct you to GPC Biotech's Annual Report on Form 20-F for the fiscal year ended December 31, 2005, Pharmion's Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of either GPC Biotech or Pharmion. Forward-looking statements speak only as of the date on which they are made and neither GPC Biotech nor Pharmion undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
The scientific information discussed in this press release related to satraplatin is investigative. Satraplatin has not yet been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
Source: GPC Biotech
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