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.
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.
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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.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation 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.
Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals
bayerpharma
onyx-pharm
melanomainternational
nexavar
View drug information on Nexavar.
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