Bayer and Onyx Announce Results of Phase I Studies Evaluating BAY 43-9006 in Combination with Conventional Chemotherapy Drugs
November 02 2004 - 6:00AM
PR Newswire (US)
Bayer and Onyx Announce Results of Phase I Studies Evaluating BAY
43-9006 in Combination with Conventional Chemotherapy Drugs WEST
HAVEN, Conn. and RICHMOND, Calif., Nov. 2 /PRNewswire-FirstCall/ --
Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX) announced results from several
Phase I clinical trials of BAY 43-9006 administered in combination
with conventional chemotherapy drugs in patients with various tumor
types including, hepatic cancer and colorectal cancer. The data
were presented at the 29th European Society of Medical Oncology
(ESMO) meeting in Vienna, Austria. Data from these Phase I safety
and pharmacokinetic (metabolism) interaction studies showed that
BAY 43-9006 could be combined with the other anticancer agents
evaluated (doxorubicin, oxaliplatin, fluorouracil and leucovorin).
In addition, data show that BAY 43-9006 required no dose adjustment
when administered with ketoconazole (CYP3A inhibitor). Safety data
generated across all studies showed no unexpected treatment-related
adverse events. BAY 43-9006, a novel RAF kinase and VEGFR inhibitor
under investigation for the treatment of different types of cancer,
combines two anticancer activities: inhibition of tumor cell
proliferation and angiogenesis (the growth of new blood vessels).
BAY 43-9006 ESMO Data BAY 43-9006 data being presented at this
year's ESMO meeting include: -- Results of a Phase I trial of BAY
43-9006 in combination with doxorubicin in patients with primary
hepatic cancer. H. Richly, MD. -- Results of a Phase I combination
trial of BAY 43-9006 with oxaliplatin in patients with colorectal
cancer. P. Kupsch, MD. -- Phase I trial of BAY 43-9006 in
combination with 5-fluorouracil (5-FU) and leucovorin (LCV) in
patients with advanced refractory solid tumors. A. Figer, MD. -- A
randomized Phase I clinical and biologic study of two schedules of
the C-RAF kinase inhibitor BAY 43-9006 in patients with
Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML): A
NCI Canada Clinical Trials Group study. M. Crump, MD. -- Lack of
effect of ketoconazole, a CYP3A inhibitor, on BAY 43-9006 clinical
pharmacokinetics. C.D. Lathia, Ph. D. About BAY 43-9006 BAY
43-9006, a novel investigational drug candidate, has demonstrated
anti-proliferative and anti-angiogenic properties -- two important
anticancer activities. In preclinical models, BAY 43-9006 inhibited
tumor cell proliferation by targeting the RAF/MEK/ERK signaling
pathway at the level of RAF kinase. BAY 43-9006 also exerted an
antiangiogenic effect by targeting the receptor tyrosine kinases
VEGFR-2 and PDGFR and their associated signaling cascades. BAY
43-9006 is currently undergoing Phase III evaluation for the
treatment of advanced kidney cancer and Bayer and Onyx intend to
initiate additional Phase II and Phase III trials in other tumor
types. For more information on BAY 43-9006 clinical trials, visit
http://www.clinicaltrials.gov/ . About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel
cancer therapies that target the molecular basis of cancer. With
its collaborators, the company is developing small molecule drugs,
including BAY 43-9006 with Bayer Pharmaceuticals Corporation. For
more information about Onyx's pipeline and activities, visit the
company's web site at: http://www.onyx-pharm.com/ . About Bayer
Pharmaceuticals Corporation Bayer Pharmaceuticals Corporation (
http://www.bayerpharma.com/ ) is part of the worldwide operations
of Bayer HealthCare AG, a subgroup of Bayer AG. Bayer HealthCare,
with sales of approximately 8.9 billion Euro in 2003, is one of the
world's leading, innovative companies in the health care and
medical products industry. The company combines the global
activities of the divisions Animal Health, Biological Products,
Consumer Care, Diagnostics and Pharmaceuticals. About 34,600 people
are employed by Bayer HealthCare worldwide. Our aim is to discover
and manufacture innovative products that will improve human and
animal health worldwide. Our products enhance well being and
quality of life by diagnosing, preventing and treating disease.
Forward-Looking Statements 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). Bayer
assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of
Onyx within the meaning of the federal securities laws. These
forward-looking statements include without limitation, statements
regarding the timing, progress and results of the clinical
development, regulatory processes and commercialization efforts of
BAY 43-9006. These statements are subject to risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated. Reference should be made Onyx's
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 15, 2004 under the heading "Additional Business
Risks" and Onyx's subsequent Quarterly Reports on Form 10-Q for a
more detailed description of such factors. Readers are cautioned
not to place undue reliance on these forward-looking statements
that speak only as of the date of this release. Onyx undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events or circumstances after the date of
this release except as required by law. DATASOURCE: Bayer
Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc. CONTACT:
Mark Bennett of Bayer Pharmaceuticals Corporation, +1-203-812-2160;
Helmut Schaefers of Bayer HealthCare Communications,
+49-214-30-58308; Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-262-8757; Geoff Curtis of GCI Group, +1-312-229-8702 Web
site: http://www.bayerpharma.com/ http://www.onyx-pharm.com/
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