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BAY 43-9006 Phase I Data Presented at 2001 AACR-NCI-EORTC Meeting 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. Onyx Pharmaceuticals is engaged in the discovery and development of novel cancer therapies. Based on its proprietary virus technologies, the company is developing its lead product, ONYX-015. ONYX-015 is currently in a Phase III clinical trial for head and neck cancer. For more information about Onyx`s pipeline and activities, visit the company`s web site at www.onyx-pharm.com. Bayer Pharmaceuticals is addressing the unmet medical needs of people with cancer by discovering and developing novel therapeutic approaches to the disease. Bayer has initiated Phase I studies in four new anticancer therapies. Already a leader in developing diagnostic techniques for identifying cancers: Bayer is investing $1 billion annually in life-science research. This press release may contain certain forward-looking statements regarding the development of potential human therapeutic products that involve a number of risks and uncertainties. Actual events may differ from the company`s expectations. In addition to the matters described in this press release, the timeline for clinical activity, results of pending or future clinical trials, and changes in the status of the company`s collaborative relationships, as well as the risk factors listed from time to time in the company`s periodic reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K, may affect the actual results achieved by the company. SOURCE: Onyx Pharmaceuticals, Inc. --------------------------------------------------------- Study Results Highlight Onyx`s Oncolytic Virus Pipeline RICHMOND, Calif., Nov. 1 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - news) -- Novel data was presented this week at the 12th Annual American Association for Cancer Research-National Cancer Institute-European Organization for the Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference in Miami, Florida. Researchers presented two abstracts covering Onyx`s next-generation virus research, as well as one abstract which describes novel ONYX-015 clinical data in patients with sarcoma. ``These data add to the growing body of evidence showing that Onyx`s technology platform has significant potential benefits to the oncology community,`` said Leonard Post, Ph.D., Senior Vice President of Research and Development at Onyx. Data on ONYX-411, a new virus that selectively propagates in tumor cells having a deregulated pRb-signaling pathway, was highlighted in poster presentation today. Extensive pre-clinical studies have shown that ONYX-411 is unable to propagate in normal human cells, yet efficiently kills human tumor cells of diverse origin. Data presented today show that when given intravenously at high doses to mice bearing human tumor xenografts, ONYX-411 demonstrated significant anti-tumor efficacy, without associated toxicity to normal organs. Further, yesterday, researchers at Onyx presented promising data on its cytosine deaminase (CD) Armed Therapeutic Virus(TM) (ATV) product candidate. CD, an enzyme that converts 5-FC into its highly cytotoxic form, 5-FU, is a commonly used first-line chemotherapeutic agent. ATV is a proprietary technology in which therapeutic genes are placed strategically into Onyx viruses such that expression occurs as a condition of virus replication. Therefore, as replication of Onyx viruses occurs preferentially within cancer cells, expression of the therapeutic transgene is focused within the tumor. In data presented from pre-clinical animal studies, researchers at Onyx showed that CD-ATV provided an enhanced anti-tumor response in the presence of 5-FC, and correlated with high intra-tumoral concentrations of 5-FU, but sub-toxic levels sytemically. ``An extension of the ONYX-015 technology platform designed to increase both the extent and durability of anti-tumor responses, the CD-ATV represents an important next step in the growth of Onyx`s product pipeline,`` added Dr. Post. Finally, researchers at the Mayo Clinic presented novel ONYX-015 data in chemotherapy-naive patients with sarcoma. In this ongoing dose-escalating Phase I/II study, four patients have been treated to date with ONYX-015 administered via intratumoral injections in combination with a chemotherapy regimen consisting of mitomycin-C, doxorubicin and cisplatin. No serious toxicities related to ONYX-015 have been documented thus far, and ongoing accrual at the highest dose level will allow for a future assessment of efficacy. Sarcomas are tumors of the connective tissues, and approximately 40-75% of sarcomas contain p53 functional mutations. There are approximately 9,800 new cases of sarcoma each year in the United States. Onyx Pharmaceuticals is engaged in the discovery and development of novel cancer therapies. Based on its proprietary virus technologies, the company is developing its lead product, ONYX-015, which is currently in a Phase III clinical trial for recurrent head and neck cancer. For more information about Onyx`s pipeline and activities, visit the company`s web site at www.onyx-pharm.com. This press release may contain certain forward-looking statements regarding the development of potential human therapeutic products that involve a number of risks and uncertainties. Actual events may differ from the company`s expectations. In addition to the matters described in this press release, the timeline for clinical activity, results of pending or future clinical trials, and changes in the status of the company`s collaborative relationships, as well as the risk factors listed from time to time in the company`s periodic reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K, may affect the actual results achieved by the company. SOURCE: Onyx Pharmaceuticals, Inc. |
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| aus der Diskussion: | onyx pharmaceut. im juhu musterdepot! |
| Autor (Datum des Eintrages): | panik (05.11.01 20:37:01) |
| Beitrag: | 43 von 229 (ID:4801421) |
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