Bayer and Onyx Announce Phase II Results of Treatment With BAY 43-9006 in Patients with Advanced Primary Liver Cancer
29 September 2004 - 9:00PM
PR Newswire (US)
Bayer and Onyx Announce Phase II Results of Treatment With BAY
43-9006 in Patients with Advanced Primary Liver Cancer 52 Percent
of Patients Experienced Disease Stabilization or Tumor Shrinkage
WEST HAVEN, Conn., and RICHMOND, Calif., Sept. 29
/PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation
(NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced results from a Phase II clinical trial of BAY 43-9006
administered as a single agent in patients with advanced
hepatocellular carcinoma (HCC), or liver cancer (hepatoma). The
data were presented at the 16th American Association for Cancer
Research -- National Cancer Institute -- European Organization for
Research and Treatment of Cancer (AACR-NCI-EORTC) meeting in
Geneva, Switzerland. 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). "In this Phase II study of advanced primary liver cancer,
43 percent of patients treated with BAY 43-9006 experienced stable
disease for at least four months and an additional nine percent of
patients experienced tumor shrinkage," said Dr. Ghassan K.
Abou-Alfa, lead investigator and clinical assistant attending at
the Memorial Sloan-Kettering Cancer Center, New York, U.S.A. "As we
continue to evaluate BAY 43-9006, this clinical study offers a
promising step in the fight against primary liver cancer, a disease
that has very limited treatment options." Of 137 patients enrolled
in the study, investigators reported seven patients with partial
responses (tumor shrinkage of 50 percent or greater), five with
minor responses (tumor shrinkage of 25 to 50 percent) and 59 with
stable disease for at least four months as their best response.
Median overall survival for all patients was 9.2 months and median
time-to-tumor progression (TTP) was 4.2 months. In the study,
safety data generated showed that BAY 43-9006 was well tolerated
and side effects were predictable and manageable. The most common
grade 3/4 drug-related toxicities were fatigue (9.5 percent),
diarrhea (8 percent), and hand-foot skin reaction (5 percent).
"More than 500,000 people worldwide succumb to hepatocellular
carcinoma each year. The disease is increasing in incidence rates
and remains one of the most difficult tumor types to treat. We are
encouraged by the signs of activity of BAY 43-9006 in HCC patients
enrolled in this study," said Susan Kelley, M.D., vice president,
Oncology, Bayer Pharmaceuticals Corporation. "Based on these
preliminary data, we will be advancing the BAY 43-9006 clinical
development program in HCC and will be initiating a Phase III
single-agent study as well as a Phase II combination study with the
chemotherapy agent doxorubicin." Phase II Study Design The BAY
43-9006 Phase II multi-center study enrolled 137 patients with
inoperable HCC who had received no prior systemic treatment, had
Child-Pugh score A or B (a measure of the severity of liver failure
in cirrhosis) and an Eastern Cooperative Oncology Group (ECOG)
performance status less than or equal to one. Patients received
oral BAY 43-9006 at 400 mg twice a day continuously in four-week
cycles. The goal of the study was to assess time to response,
duration of response/stable disease, time to progression, overall
survival and safety. Tumor response was assessed every eight weeks
using World Health Organization (WHO) criteria. 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 has shown anticancer activity in a
number of tumor types. It is being evaluated both as a single agent
therapy and in combination with conventional chemotherapeutics in a
number of ongoing clinical trials. For more information on BAY
43-9006 clinical trials, visit http://www.clinicaltrials.gov/ .
About Hepatocellular Carcinoma Hepatocellular carcinoma, also known
as primary liver cancer, is the most common form of liver cancer
and is responsible for 80 percent of the primary malignant liver
tumors in adults. It is the fifth most common cancer in the world.
In 2000, approximately 564,000 HCC cases were reported worldwide,
with 11,500 cases in the United States and 50,000 in Europe. HCC is
most prevalent in developing countries, particularly in East and
South-east Asia, the Pacific Basin, and sub-Saharan Africa. Of the
564,000 cases worldwide approximately 271,500 were reported in
Eastern Asia (with 221,000 in China and 33,000 in Japan alone). HCC
causes more than 500,000 deaths annually worldwide. The five-year
relative survival rate is about seven percent. Additional BAY
43-9006 AACR-NCI-EORTC Data Additional BAY 43-9006 data being
presented at this year's AACR-NCI-EORTC meeting include: -- Phase I
study of BAY 43-9006, a novel RAF kinase and VEGRF inhibitor, in
combination with taxotere in patients with advanced, solid tumors.
A. Awada, MD. (Poster #381) -- Phase II antitumor activity of BAY
43-9006, a novel RAF kinase and VEGRF inhibitor, in patients with
sarcoma enrolled in a randomized discontinuation study. I. Judson,
MD. (Poster #382) 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: Onyx
Pharmaceuticals, Inc.; Bayer Pharmaceuticals Corporation CONTACT:
Mark Bennett of Bayer Pharmaceuticals Corporation, +1-203-314-5556,
onsite, or 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.onyx-pharm.com/ http://www.bayerpharma.com/
http://www.clinicaltrials.gov/
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