>>RICHMOND, Calif. and WEST HAVEN, Conn., Nov. 1 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - news) and Bayer Corporation -- Phase I data from clinical trials conducted at the Jules Bordet Institute of Belgium, the Hamilton Regional Cancer Centre and the Princess Margaret Hospital of Canada were presented today for BAY 43-9006, a small molecule Raf kinase inhibitor, at the 12th Annual American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference in Miami, Florida. BAY 43-9006 was codiscovered and is being developed by Onyx and Bayer.
BAY 43-9006 is a member of an emerging class of therapeutics directed toward specific molecular targets misregulated in cancer. BAY 43-9006 selectively blocks signal transduction in the Ras pathway by inhibiting a specific enzyme known as Raf kinase, and is the first orally active compound in this class to undergo clinical testing. The Ras signaling pathway is believed to play an integral role in the genesis of many cancers, and 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 40 percent of lung cancers.
The preliminary data presented today demonstrate the safety, pharmacokinetics and pharmacodynamics of BAY 43-9006 as an anticancer agent in patients with advanced malignancies. In the data presentations, 40 patients with various cancers have been treated in two Phase I clinical trials. BAY 43-9006 has been administered orally at various schedules. Treated patients had advanced cancers including, colorectal, hepatocellular, breast, non-small cell lung, and other cancers. Few adverse events or toxicities clearly related to BAY 43-9006 were reported in the three studies. Patients enrolled in these trials have achieved serum BAY 43-9006 levels equivalent to the levels at which anti-tumor activity was seen in pre-clinical studies. ``In the Canadian study, BAY 43-9006 has been well-tolerated with no consistent grade 3/4 adverse events and no dose limiting toxicities reported up to 100 mg po bid. The study is ongoing and is currently observing 4 patients on 200 mg bid,'' said Dr. Hal Hirte of the Hamilton Regional Centre.
``Presentations on BAY 43-9006 at this meeting provide us with an opportunity to emphasize Onyx's second product in clinical development,'' said Hollings C. Renton, Chairman of the Board and Chief Executive Officer of Onyx. ``We are pleased that the current preliminary experience with BAY 43-9006 suggests that this agent warrants further study in patients with a wide range of tumor types. Onyx and Bayer anticipate the completion of several Phase I studies in the near term and the initiation of additional clinical trials in the coming months. Bayer has already initiated a Phase I study in patients with acute myelogenous leukemia, as well as in patients with myelodysplastic syndrome. Onyx and Bayer plan to expand this study to a Phase II study after completing the Phase I dose escalation 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 marketing activities worldwide except for Japan. Onyx is developing BAY 43-9006 in partnership with Bayer Corporation.<<
snip
Cheers, Tuck |
