Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
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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/