Message 14852036
Initial PI results didn't reach criteria to take position or discuss compound.
So, let say 6-9 months more before they have something interesting to report.
Miljenko
[eom]
Monday March 26, 6:30 am Eastern Time
Press Release
SOURCE: Onyx Pharmaceuticals, Inc.
Onyx and Bayer Present Phase I Study Results of Novel Oral Raf Kinase Inhibitor for Treatment of Cancer
BAY 43-9006 First Orally Active Compound in Class to Undergo Clinical Testing
NEW ORLEANS and RICHMOND, Calif., March 26 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - news) and its development partner, Bayer Corporation, presented today Phase I clinical results of the companies' novel oral Raf kinase inhibitor, known as BAY 43-9006. The study was presented today at the 92nd Annual Meeting of the American Association for Cancer Research (AACR). The companies also announced results of preclinical studies of BAY 43-9006, which demonstrated the compound's mechanism of action and its potential applicability in multiple tumor types.
BAY 43-9006 is a selective agent designed to block the Ras signaling pathway in cells by inhibiting a specific enzyme known as Raf kinase. The Ras signaling pathway is believed to play an integral role in the growth of certain cancer tumors, and that blocking this pathway could inhibit tumor growth. Mutations in the Ras gene occur in approximately 30 percent of all human cancers, including 90 percent of pancreatic cancer, 50 percent of colon cancer and some lung cancers. BAY 43-9006 is the first orally active compound in this class to undergo clinical testing.
``The AACR data suggest that BAY 43-9006 may have activity across a range of tumor types,'' said Hollings Renton, Onyx's Chairman and Chief Executive Officer. ``Phase I studies in Germany, U.S., Canada and Belgium are ongoing and should be completed later this year. We look forward to moving ahead quickly with further clinical development of this promising compound.''
Wolfgang Plischke, Bayer's President of the North America Pharmaceutical Division, is encouraged by the research to this point. ``There is an increasing need for new therapy development. By building alliances with the scientific community and industry thought leaders we're able to accelerate the research of anticancer therapies.''
The goal of the Phase I study was to determine the dose-limiting toxicity, maximum-tolerated dose, pharmacokinetic properties and pharmacodynamic determinants of BAY 43-9006. Twelve patients with refractory solid tumors were treated once every week with single oral doses of BAY 43-9006, ranging from 50 to 400 mg., given at increasing doses. No toxicities have been observed to date.
The companies also presented the results of pre-clinical studies at the AACR meeting demonstrating that BAY 43-9006 inhibits Raf kinase signal transduction. In multiple xenograft tumor models, dose-dependent tumor growth inhibition from 44 to 81 percent was observed. These preclinical data suggest that BAY 43-9006 is an orally available Raf kinase inhibitor with broad antitumor efficacy that suggests the potential for clinical utililty upon further study.
Onyx has collaborated with Bayer since 1994 to discover, develop and commercialize anticancer compounds that inhibit the function or modulate the activity of the Ras pathway. The agreement provides for sharing clinical development costs and resulting profits worldwide except for Japan. |
