Satraplatin in patients with advanced hormone-refractory prostate cancer: Overall survival results from the phase III satraplatin and prednisone against refractory cancer (SPARC) trial, A. Oliver Sartor, MD (Abstract #5003)
Data from this oral presentation are discussed in a separate press release issued by GPC Biotech on June 2, 2008.
Additional data on satraplatin and on RGB-286638 broad-spectrum kinase inhibitor published in ASCO Annual Meeting Proceedings
The Company also reported that data from two other satraplatin clinical trials, as well as in vitro data in multiple myeloma with the RGB-286638 kinase inhibitor, were published in the ASCO Annual Meeting Proceedings.
Cirstea, Diana et al, “Pleiotropic Activity of the Novel Cyclin-Dependent Kinase Inhibitor RGB 286638 Predicts Therapeutic Potential in Multiple Myeloma.” Researchers assessed the effect of RGB-286638, a novel broad-spectrum kinase inhibitor, on inhibiting tumor growth in conventional drug-sensitive and drug-resistant multiple myeloma cell lines and primary tumor cells from multiple myeloma patients. The results demonstrated that RGB-286638 induces multiple myeloma cell death via the inhibition of cyclin-dependent kinase/cyclin complexes and cell cycle progression. In vivo studies are ongoing to assist in the design of clinical testing for RGB-286638 in multiple myeloma.
Spigel, D R et al, “Phase II Trial of Satraplatin (S) and Paclitaxel (P) in First-Line Advanced Non-Small Cell Lung Cancer (NSCLC) Treatment: Final Results.” This abstract reviewed the final results from the Phase 2 trial evaluating satraplatin plus paclitaxel (Taxol®) in patients with NSCLC. Thirty-eight patients with newly-diagnosed NSCLC were enrolled in the study, and 28 patients were evaluable. One complete response and six partial responses were observed (25.9% overall response rate). The regimen was well tolerated and associated with limited Grade 3/4 toxicity when satraplatin was administered at 70 mg/m2 on days 1-5 every 28 days. The results indicate that satraplatin appears to have activity that is similar to other platinum agents when combined with paclitaxel in first-line NSCLC treatment.
Wisinski, K B et al, “A phase I study of the oral platinum agent satraplatin (S) with capecitabine (C) in patients (pts) with advanced solid malignancies.” This abstract discussed results from a Phase 1 study evaluating the combination of satraplatin and capecitabine administered concurrently. Twenty-two patients were enrolled in the study. The dose-limiting toxicities were predominantly Grade 3/4 thrombocytopenia. The MTD for satraplatin was 100 mg/m2 on days 1-5. No responses were observed, and there was significant toxicity when these two compounds were administered together. [Abstract on data from trial evaluating sequential administration of satraplatin with capecitabine discussed earlier in this release.]
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. A Marketing Authorization Application for satraplatin in combination with prednisone is currently under review in Europe for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. A decision on the filing by the European regulators is expected in the second half of 2008. Celgene Corporation is responsible for the regulatory filings for satraplatin and its development and commercialization for Europe and certain other territories. GPC Biotech also has a license agreement with Yakult Honsha Co. Ltd. under which Yakult has exclusive commercialization rights to satraplatin for Japan and is taking the lead in developing the drug in that territory. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
