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Novel RAF Kinase Inhibitor Bay 43-9006 Shows Early Signs of Tolerability and Activity in Phase Ib Combination Trials Reported at ASCO Monday June 2, 11:22 am ET Final Data from Phase I Single-Agent Studies also Presented WEST HAVEN, Conn. and RICHMOND, Calif., June 2 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced at the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago encouraging Phase Ib data from two clinical trials of BAY 43-9006, a novel, investigational RAF kinase inhibitor, in combination with standard chemotherapeutics, as well as final Phase I results that confirm and extend the positive findings presented at international medical meetings in 2002. This novel inhibitor is an orally active small molecule agent currently in Phase II clinical development in a collaboration between Bayer and Onyx. The data describe safety findings and preliminary antitumor activity from multiple Phase Ib chemotherapy combination trials and Phase I single-agent clinical trials. ADVERTISEMENT AMERITRADE SPECIAL OFFER · 30 commission-free trades Start trading on us · Command center screen Get this FREE service · Our 10-Second Guarantee (restrictions apply) Start getting your share with us Open your account now Phase Ib Clinical Study: BAY 43-9006 in Combination with Gemcitabine (Abstract 828) Safety, pharmacokinetics and tumor response rate from a multicenter Phase Ib study of BAY 43-9006 in combination with gemcitabine were presented today in a poster presentation by Lillian L. Siu, M.D., of Princess Margaret Hospital in Toronto, Canada. The study was a dose-escalating Phase Ib trial, in which BAY 43-9006 was administered continuously at three different dose levels up to 400 mg twice daily, along with gemcitabine given at the standard dose of 1000 mg/m2. The patients had advanced solid tumors including pancreatic, colorectal, ovarian, esophageal, gastric, liposarcoma, nasopharyngeal and mesothelioma, for which no standard therapy exists and who were deemed suitable for treatment with gemcitabine chemotherapy. The safety results were reported in 20 patients treated on study. Hematological toxicities observed in the clinical data were non-dose limiting and consistent with gemcitabine effects. Non-hematological toxicities included decreased appetite, fatigue, hand-foot syndrome, skin rash, nausea and diarrhea. Only fatigue proved dose-limiting in one patient treated at the highest dose. Preliminary pharmacokinetic analysis revealed no significant interactions between BAY 43-9006 and gemcitabine. Data from 20 patients included one patient with a confirmed partial response in previously treated ovarian cancer, and disease stabilization of eight weeks or more in 11 patients with tumor types including: ovarian, pancreatic, colorectal, nasopharyngeal, and an unknown primary tumor. An expanded cohort of pancreatic cancer patients is currently being evaluated in this study. Phase Ib Clinical Study: BAY 43-9006 in Combination with Carboplatin and Paclitaxel (Abstract 2854) Data from a second chemotherapy combination Phase Ib study of BAY 43-9006 were presented Saturday, May 31, at an ASCO session devoted to melanoma and described in an announcement issued that day by the University of Pennsylvania. The multicenter, dose-escalating trial was designed to evaluate different dosage levels of BAY 43-9006 administered in combination with carboplatin and paclitaxel. Thus far, 20 patients with a variety of tumor types have been treated in the study. In an oral presentation, Keith T. Flaherty, M.D., of the University of Pennsylvania reported that BAY 43-9006 was well tolerated when combined with full dose carboplatin and paclitaxel. Toxicities, including skin rash and hand-foot syndrome, resolved themselves. No pharmacokinetic interaction between BAY 43-9006 and paclitaxel or carboplatin was reported. Dr. Flaherty reported confirmed partial responses in three of ten evaluable patients with melanoma, and disease stabilization in six additional melanoma patients, four of whom showed evidence of tumor necrosis. "These trials are two of eight ongoing studies evaluating BAY 43-9006 in combination with a range of standard chemotherapeutic agents," stated Susan Kelley, M.D., Vice President of Oncology Product Development at Bayer Pharmaceuticals. "Further evaluation of BAY 43-9006 administered in combination with these cytotoxic drugs is warranted, based on these preliminary data. We are encouraged by the non-overlapping toxicity profiles and early indications of activity in the clinical setting." Phase I Clinical Trials: Single-Agent BAY 43-9006 (Abstract 793) Final data from single-agent Phase I clinical trials of BAY 43-9006 were presented today in a poster session by Dirk Strumberg, M.D., of the West German Cancer Center at the University of Essen. This report included data from four clinical Phase I single agent studies conducted at the University of Essen, the Jules Bordet Institute in Belgium, the Hamilton Regional Cancer Centre and Princess Margaret Hospital in Canada, and the Dana Farber Cancer Institute and the University of Southern California in the United States. In an analysis of 118 patients with advanced malignancies who received BAY 43-9006 doses of 200 mg twice daily or higher, 29 patients remained on BAY 43-9006 for more than six months, with no tumor progression or serious treatment-related adverse events. Of these, nine were on treatment for more than one year, with no disease progression or serious treatment-related adverse events. Durable partial responses were also observed in one liver cancer patient and one kidney cancer patient. Most of the dose-limiting toxicities were seen at dose levels of 600 mg twice daily or greater and included diarrhea and skin toxicity. "These results from our now-completed single-agent Phase I program for BAY 43-9006 show signs of a favorable safety profile and preliminary antitumor activity," stated Dr. Kelley. "Phase II clinical trials are ongoing, and we are making preparations for the start of phase III." About BAY 43-9006 BAY 43-9006 is a novel investigational compound directed against a specific molecular target involved in excess growth signaling in cancer. BAY 43-9006 blocks the enzyme RAF kinase, which is a critical component of the RAS pathway -- an important cascade of chemical signals that control cell division. Activating mutations of a RAS gene are estimated to occur in almost one-third of human cancers, including 90 percent of pancreatic cancer, 50 percent of colon cancer and 30 percent of non-small cell lung cancer. In addition, recent research suggests that a specific RAF kinase, BRAF, is activated by mutation in two-thirds of melanomas and smaller percentages of several other cancers. The codevelopment collaboration between Onyx and Bayer results in Onyx funding 50 percent of the development costs for BAY 43-9006. In return, Onyx has a 50/50 profit share in the United States, where the companies can co-promote the product. Everywhere else in the world except Japan, Onyx`s share is somewhat less than 50 percent since Bayer has exclusive marketing rights. In Japan, Bayer funds product development, and Onyx receives a royalty. About Onyx Pharmaceuticals Onyx Pharmaceuticals is engaged in the discovery and development of novel cancer therapies and has proprietary technologies that target the molecular basis of cancer. The company is developing small molecule drugs, including BAY 43-9006 in codevelopment with Bayer. In addition, the company`s preclinical portfolio includes proprietary therapeutic viruses and Armed Therapeutic Virus(TM) products. For more information about Onyx`s pipeline and activities, visit the company`s website at www.onyx-pharm.com . About Bayer Pharmaceuticals Corporation Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world`s leading innovators in the health care and medical products industry. Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal Health and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare. Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease. This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer`s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F) and Onyx`s public reports filed with the U.S. Securities and Exchange Commission (including its Form 10-K). The companies assume no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. -------------------------------------------------------------------------------- Source: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc. |
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| aus der Diskussion: | onyx pharmaceut. im juhu musterdepot! |
| Autor (Datum des Eintrages): | panik (02.06.03 22:19:55) |
| Beitrag: | 74 von 229 (ID:9630959) |
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