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Nexavar Shown To Significantly Extend Survival For Patients With Advanced Liver Cancer
Bayer Pharmaceuticals Corporation (NYSE: BAY) and
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that an
independent data monitoring committee (DMC) has reviewed the safety and
efficacy data from the companies' pivotal Phase 3 trial in patients with
advanced hepatocellular carcinoma (HCC), or primary liver cancer. Based on
this planned interim analysis, the DMC has concluded that the trial met its
primary endpoint resulting in superior overall survival (OS) in those
patients receiving Nexavar(R) (sorafenib) tablets versus those patients
receiving placebo. The DMC also noted that there was no demonstrated
difference in serious adverse event rates between the two treatment arms
(Nexavar and placebo). Based on these conclusions, the DMC recommended that
the trial be stopped early.
As a result of this recommendation, Bayer and Onyx will stop the trial
and allow all patients enrolled in this trial access to Nexavar. Given that
there are limited approved systemic therapies for this disease, the
companies will continue discussions with health authorities worldwide,
including the U.S. Food and Drug Administration (FDA) and European health
authorities regarding the next steps in filing for approval for the
treatment of HCC. Following these discussions, the companies will proceed
to file as rapidly as possible. The two companies also reported that they
plan to submit the results from the trial to the American Society of
Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5,
2007.
"The observed superiority in overall survival for Nexavar-treated
patients over patients receiving placebo demonstrates the efficacy of
Nexavar in advanced primary liver cancer," said Dr. Jordi Bruix,
co-principal investigator and Head of the Barcelona Clinic Liver Cancer
Group, Liver Unit, Hospital Clinic Barcelona, Spain.
Dr. Josep M. Llovet, co-principal investigator and Associate Professor
of Medicine/Director, HCC Research Program, Division of Liver Diseases,
Mount Sinai School of Medicine, New York, and Professor of Research at
Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona
added, "These results point to new potential treatment options for those
patients suffering from this devastating disease."
About the SHARP Trial
This analysis was conducted using data from the Sorafenib HCC
Assessment Randomized Protocol (SHARP) Trial, an international Phase 3
double-blind, randomized, placebo-controlled trial designed to evaluate
Nexavar in patients with advanced HCC, or primary liver cancer, who had no
prior systemic therapy. Six hundred and two patients were randomized and
enrolled at sites in the Americas, Europe, and Australia/New Zealand. The
primary objectives of the study are to compare OS and time to symptom
progression (TTSP) in patients administered Nexavar versus those patients
administered placebo.
About Hepatocellular Carcinoma
Hepatocellular carcinoma, also known as primary liver cancer, is the
most common form of liver cancer and is responsible for about 90 percent of
the primary malignant liver tumors in adults. It is the fifth most common
cancer in the world.
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-1, VEGFR-2,
VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also
demonstrated that Raf/MEK/ERK has a role in HCC, therefore blocking
signaling through Raf-1 may offer therapeutic benefits in HCC.
Nexavar is currently approved in nearly 50 countries, including the
United States and in the European Union, for the treatment of patients with
advanced kidney cancer. In addition, Nexavar is being evaluated by the
companies, international study groups, government agencies or individual
investigators as a single agent or combination treatment in a wide range of
cancers, including adjuvant RCC, advanced liver cancer, metastatic
melanoma, non-small cell lung cancer and breast cancer.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently 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.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing
innovative therapies that target the molecular mechanisms that cause
cancer. The company is developing Nexavar(R), a small molecule drug, with
Bayer Pharmaceuticals Corporation. Nexavar has been approved for the
treatment of advanced kidney cancer. 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 HealthCare, a subsidiary of Bayer AG, is one of the world's
leading, innovative companies in the healthcare and medical products
industry and is based in Leverkusen, Germany. The company combines the
global activities of the Animal Health, Consumer Care, Diabetes Care, and
Pharmaceuticals divisions. The Pharmaceuticals division comprises the
following business units: Women's Healthcare, Diagnostic Imaging,
Specialized Therapeutics, Hematology/Cardiology, Primary Care, and
Oncology. Bayer HealthCare's aim is to discover and manufacture products
that will improve human and animal health worldwide. The products enhance
well-being and quality of life by diagnosing, preventing and treating
diseases.
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 and Onyx Pharmaceuticals, Inc.
http://www.onyx-pharm.com
View drug information on Nexavar.
Nexavar dovedit a extinde în mod semnificativ supravieþuirea pentru pacienþii cu cancer avansat de ficat - Nexavar Shown To Significantly Extend Survival For Patients With Advanced Liver Cancer - articole medicale engleza - startsanatate