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Encouraging Data on BAY 43-9006 in Combination With Standard
Chemotherapeutics as Melanoma Treatment Presented at American Society of
Clinical Oncology Meeting
40 Percent of Patients have Durable Partial Responses
NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals
Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced encouraging interim results from a Phase l/II clinical trial of BAY
43-9006 administered in combination with the chemotherapeutic agents
carboplatin and paclitaxel to treat patients with advanced malignant melanoma.
The data were presented at the annual meeting of the American Society of
Clinical Oncology in New Orleans.
BAY 43-9006, a novel RAF kinase and VEGFR inhibitor under investigation for the
prevention of tumor growth, combines two anticancer activities: inhibition of
tumor cell proliferation and tumor angiogenesis.
The evaluation included 35 study participants in the Phase I/II study, the
majority of whom had advanced metastatic melanoma. Eighty three percent of
study participants treated with the combination of BAY 43-9006 plus carboplatin
and paclitaxel were observed to have tumor shrinkage (40 percent) or disease
stabilization (43 percent) while on study treatments. Of the 35 study
participants, fourteen participants (40 percent) had tumor shrinkage of 50
percent or greater, all of which lasted for six months or more. At the time of
this analysis, only three of these participants had disease progression at 10
to 12 months. An additional 15 participants (43 percent) had disease
stabilization. Six participants had disease progression or exited the trial
for other reasons. For all study participants, estimated median time to
disease progression (TTP) was 10 months based on investigator assessment.
Trial data are subject to final independent review at the end of the study.
"These are encouraging results as a majority of these patients had metastases
to visceral organs. Despite the severity of their disease, we observed 40
percent of the patients as having partial responses for a prolonged period of
time," said lead investigator Keith T. Flaherty, M.D., instructor of medicine,
Abramson Cancer Center, University of Pennsylvania. "In a disease with limited
treatment options, these preliminary findings are encouraging."
According to the study data, this combination demonstrated activity that was
not solely dependent on a BRAF gene mutation to activate the Ras pathway. BRAF
gene mutations, of which V599E is the most common form, are thought to occur in
about two-thirds of malignant melanoma tumors.
"The data from this study using the combination of BAY 43-9006 with carboplatin
and paclitaxel appeared more encouraging than that obtained when BAY 43-9006
was administered as a single agent in other clinical experience," said Susan
Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation.
"Bayer and Onyx are pleased with the data generated to date and are planning a
pivotal trial with this combination."
In the study, the non-hematologic side effects observed with the combination
were consistent with those known to occur with each agent delivered alone. The
most common included hand-foot syndrome, infection, vomiting, and rash. No
pharmacokinetic interaction between BAY 43-9006 and paclitaxel or carboplatin
was reported.
Phase l/Phase II Study Design
Initially designed to evaluate the safety and preliminary efficacy of BAY
43-9006 administered in combination with carboplatin and paclitaxel, the Phase
I/II trial was expanded to evaluate the effectiveness of the regimen in
patients with advanced melanoma patients once the safety of the combination was
observed.
About BAY 43-9006
BAY 43-9006, a novel investigational drug candidate, has demonstrated both
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.
For more information on BAY 43-9006 clinical trials, visit
http://www.clinicaltrials.gov/.
Additional BAY 43-9006 ASCO Melanoma Data
Data from a separate study of BAY 43-9006 administered as a single agent in
patients with malignant melanoma were also presented at the meeting (abstract
#7506). Tanya Ahmad, MRCP of The Royal Marsden Hospital, London, reported that
BAY 43-9006 had modest anti-tumor activity when delivered as monotherapy to
patients with advanced malignant melanoma. It was concluded from these
preliminary data that BAY 43-9006 delivered in combination with standard
chemotherapeutics was a more promising therapeutic approach for patients with
this disease. The Royal Marsden currently has a study underway combining BAY
43-9006 and the chemotherapeutic agent dacarbazine for treatment of patients
with malignant melanoma.
Melanoma
Cancer of the skin (nonmelanoma and melanoma skin cancers combined) is the most
common type of cancer, accounting for more than 50 percent of all cancers.
Melanoma accounts for about 4 percent of skin cancer cases but causes about 79
percent of skin cancer deaths. About 132,000 people worldwide (about 55,000
Americans) are diagnosed with melanoma each year, and more than 37,000 (about
8,000 Americans) of them die from the disease annually. Once the disease
becomes metastatic, it is rapidly fatal due to the lack of an effective
therapy. For more information on melanoma, visit the Melanoma International
Foundation (MIF) web site at: http://www.melanomainternational.org/.
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. Bayer
HealthCare employs 34,600 people 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 BAY43-9006. 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" 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, or onsite at ASCO, +1-203-314-5556, or Helmut Schaefers of
Bayer HealthCare Communications, +49-214-30-58308; Julie Wood of Onyx
Pharmaceuticals, Inc., +1-510-262-8757, or onsite at ASCO, +1-925-247-4330;
Eileen Crowley of GCI Group, +1-212-537-8116, or onsite at ASCO,
+1-646-732-6855