Enrollment Completed in Phase III Studies of Nexavar for Patients With Metastatic Melanoma and Liver Cancer
May 03 2006 - 8:00AM
PR Newswire (US)
WEST HAVEN, Conn. and EMERYVILLE, Calif., May 3
/PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation
(NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced the completion of patient enrollment in two randomized,
double-blind, Phase III clinical trials; one administering
Nexavar(R) (sorafenib) tablets in combination with the
chemotherapeutic agents carboplatin and paclitaxel in patients with
advanced metastatic melanoma and another administering Nexavar as a
single agent in patients with advanced hepatocellular carcinoma
(HCC), or liver cancer. "Therapy with Nexavar could potentially
provide an important advancement in the treatment of these
difficult diseases, and we are pleased to have reached these
milestones," said Henry Fuchs, M.D., executive vice president and
chief medical officer of Onyx Pharmaceuticals. "While the studies
are still ongoing and analyses will not commence until the
pre-specified number of events are reached, we look forward to
generating randomized data in these indications." Trial Designs The
company-sponsored melanoma trial is designed to evaluate the safety
and efficacy of Nexavar when co-administered with chemotherapy, and
has progression-free survival as its primary endpoint.
Approximately 250 patients with disease progression following one
previous systemic chemotherapeutic treatment (with either
dacarbazine (DTIC) or temozolomide) were enrolled into the study.
In addition to a standard dosing schedule of carboplatin (AUC 6)
and paclitaxel (225 mg/m2), patients were randomized to receive
either 400 mg of Nexavar twice daily or matching placebo. The
melanoma study includes sites in the Americas, Europe, and
Australia. The Phase III study in patients with advanced HCC is
designed to measure differences in overall survival, time to
symptom progression and time to tumor progression of Nexavar versus
placebo. Approximately 560 patients who had not received previous
systemic treatment for their disease were randomized to receive 400
mg of oral Nexavar twice daily or matching placebo. The HCC study
is being conducted in the Americas, Europe, and Australia/New
Zealand. About 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. In some parts
of the world, especially among Western countries, melanoma is
becoming more common every year. In the United States, for example,
the percentage of people who develop melanoma has more than doubled
in the past 20 years. Melanoma accounts for about four percent of
skin cancer cases but causes about 79 percent of skin cancer
deaths. In 2002, about 160,000 people worldwide (about 53,000
Americans) were diagnosed with melanoma, and more than 40,000 of
them (about 7,500 Americans) died from the disease. For more
information on melanoma, visit the Melanoma International
Foundation (MIF) web site at:
http://www.melanomainternational.org/. 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 2002,
approximately 626,000 HCC cases were reported worldwide, with
15,000 cases in the United States and 53,600 in Europe. HCC is most
prevalent in developing countries, particularly in East and
Southeast Asia, the Pacific Basin, and sub-Saharan Africa. Of the
626,000 cases worldwide, approximately 410,000 were reported in
Eastern Asia (with 346,000 in China and 40,000 in Japan alone). HCC
causes more than 600,000 deaths annually worldwide. The five-year
relative survival rate is about seven percent. About Nexavar
Nexavar is an oral multi-kinase inhibitor that targets both the
tumor cell and tumor vasculature. In preclinical models, Nexavar
targeted members of two classes of kinases known to be involved in
both cell proliferation (growth) and angiogenesis (blood supply) -
two important processes that enable cancer growth. These kinases
included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.
Nexavar has been studied in more than 20 tumor types and in nearly
8,000 clinical trial patients. Nexavar is currently in Phase III
clinical trials for the treatment of advanced hepatocellular
carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin
cancer. A Phase III clinical trial in non-small cell lung cancer
(NSCLC) was initiated in February 2006. In addition to
company-sponsored trials, there are a variety of Nexavar studies
being sponsored by government agencies, cooperative groups and
individual investigators. Important Safety Considerations for U.S.
Patients Taking Nexavar Based on the current, approved package
insert for the treatment of patients with advanced kidney cancer,
hypertension may occur early in the course of therapy and blood
pressure should be monitored weekly during the first six weeks of
therapy and treated as needed. Incidence of bleeding regardless of
causality was 15% for Nexavar vs. 8% for placebo and the incidence
of treatment-emergent cardiac ischemia/infarction was 2.9% for
Nexavar vs. 0.4% for placebo. Most common treatment-emergent
adverse events with Nexavar were diarrhea, rash/desquamation,
fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4
adverse events were 38% for Nexavar vs. 28% for placebo. Women of
child-bearing potential should be advised to avoid becoming
pregnant and advised against breast-feeding. In cases of any severe
or persistent side effects, temporary treatment interruption, dose
modification or permanent discontinuation should be considered. For
U.S. Nexavar prescribing information, visit http://www.nexavar.com/
or call 1.866.NEXAVAR (1.866.639.2827). 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 Nexavar 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 subsidiary of Bayer AG. Bayer HealthCare
AG, with sales of approximately 9.4 billion Euros in 2005, is one
of the world's leading, innovative companies in the healthcare and
medical products industry. The company combines the global
activities of the Animal Health, Consumer Care, Diabetes Care,
Diagnostics and Pharmaceuticals divisions. Bayer Pharmaceuticals
Corporation is part of the new Global Pharmaceutical Division,
established January 1, 2006, which consists of the former
Biological Products and Pharmaceutical Division and now comprises
three business units: Hematology/Cardiology; Oncology and Primary
Care. Bayer HealthCare AG employed 33,800 people worldwide in 2005.
Bayer HealthCare AG's aim is to discover and manufacture innovative
products that will improve human and animal health worldwide. The
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 Nexavar. 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 to
Onyx's Annual Report on Form 10-K for the year ended December 31,
2005, filed with the Securities and Exchange Commission under the
heading "Risk Factors" and Onyx's 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.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer
Pharmaceuticals Corporation. DATASOURCE: Bayer Pharmaceuticals
Corporation; Onyx Pharmaceuticals, Inc. CONTACT: Mark Bennett of
Bayer HealthCare, +1-203-812-2160, or Julie Wood of Onyx
Pharmaceuticals, Inc., +1-510-597-6505, or Dr. Michael Diehl of
Bayer HealthCare, +49-214-30-58532, or Geoff Curtis of GCI Group,
+1-312-229-8702 Web site: http://www.bayerpharma.com/
http://www.onyx-pharm.com/ http://www.melanomainternational.org/
http://www.nexavar.com/
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