Encouraging Data on BAY 43-9006 in Combination With Standard Chemotherapeutics as Melanoma Treatment Presented at American Socie
June 06 2004 - 3:00PM
PR Newswire (US)
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
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