Navigation Links
Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial
Date:8/26/2007

Trial to be Stopped Early to Allow All Patients Access to Nexavar

WAYNE, N.J. and EMERYVILLE, Calif., Aug. 27 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a planned review by an independent data monitoring committee (DMC) found that Nexavar(R) (sorafenib) tablets significantly improved overall survival, progression free survival, and time to progression in an Asia-Pacific regional Phase 3 trial of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. Based on the DMC's recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar. Data from this study will be submitted for presentation at an upcoming scientific meeting.

The Asia-Pacific liver cancer study was conducted at the request of Asian health authorities in order to provide supplemental information on Nexavar's efficacy and safety in Asia-Pacific patient populations. Supplemental regulatory filings have been completed in several countries/regions including Europe, China and the United States for Nexavar in the treatment of liver cancer. These filings were based on positive data from the pivotal Phase 3 SHARP study announced earlier this year. Additional regulatory submissions for Nexavar in liver cancer are being finalized.

"Liver cancer incidence continues to rise in the Asia-Pacific region, due to the high prevalence of hepatitis B virus infection," said Dr. Ann-Lii Cheng, principal investigator and professor of medicine, National Taiwan University Hospital. "These study results confirm that Nexavar's efficacy and tolerability in liver cancer extends across ethnic groups and geographies and suggest that Nexavar could meet a tremendous unmet need for patients and families impacted by this devastating disease."

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.(3) Over 600,000 cases of liver cancer are diagnosed globally each year.(3) In 2002, approximately 600,000 people died of liver cancer including approximately 360,000 in China, Korea and Japan, 57,000 in Europe and 13,000 in the United States.(4) Risk factors for liver cancer include ongoing (chronic) infection with hepatitis B virus (HBV) and/or hepatitis C virus (HCV).(5)

About the Asia-Pacific Liver Cancer Study

This double-blind, randomized, placebo-controlled Phase 3 trial was designed to evaluate Nexavar in patients with advanced HCC, or primary liver cancer, who had no prior systemic therapy. The study enrolled 226 patients from sites in China, Korea and Taiwan. The primary objectives of the study were to compare overall survival, time to progression (TTP) and progression free survival (PFS) in patients administered Nexavar 400 mg twice daily versus patients administered placebo.

Nexavar's Differentiated Mechanism

Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target 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 more than 50 countries, including the United States and those in the European Union, for the treatment of patients with advanced kidney cancer. Nexavar is also 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 other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC). In addition, the companies recently confirmed that they are going to conduct a company-sponsored Phase 3 study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver 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 in patients with advanced kidney cancer 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 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 Healthcare Pharmaceuticals. For more information about Onyx's pipeline and activities, visit the company's web site at: http://www.onyx-pharm.com.

About Bayer HealthCare Pharmaceuticals

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide 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, 2006, 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.

References

1. World Health Organization. Hepatitis B. Available at:

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/.

Accessed April 10, 2007.

2. Penn State Milton S. Hershey Medical Center College of Medicine.

Malignant Hepatoma. Available at:

http://www.hmc.psu.edu/healthinfo/m/malignanthepatoma.htm. Accessed

April 10, 2007.

3. International Agency for Cancer Research. GLOBOCAN 2002. Available at:

http://www-dep.iarc.fr. Accessed April 23, 2007.

4. Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and

Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress,

Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed April 10,

2007.

5. American Cancer Society. What is Liver Cancer? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_What_is_liver_cancer_2 5.a sp.

Accessed April 10, 2007.


'/>"/>
SOURCE Bayer HealthCare Pharmaceuticals Inc.; Onyx
Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Nexavar Significantly Extends Overall Survival by 44% in Liver Cancer Patients
2. Review of Nexavar Data Presented at ASCO 2007- Investor Conference Call on June 4, 2007
3. Liraglutide provides significantly better glucose control than insulin glargine in phase 3 study
4. Arterial Plaque Significantly Reduced in Women Age 50-59 Taking Hormones, Says New Analysis of Womens Health Initiative Data
5. Prexige Study Shows Significantly Less Impact on Blood Pressure Than Ibuprofen in Osteoarthritis Patients with Controlled Hypertension
6. Lumiracoxib Study Showed Significantly Less Impact on Blood Pressure Than Ibuprofen in Osteoarthritis Patients with Controlled Hypertension
7. Actemra (tocilizumab) Significantly Improves Symptoms of Rheumatoid Arthritis Compared to a Current Standard of Care
8. Next Safety, Inc.s Innovative Drug Delivery System Will Replace Cigarettes and Significantly Advance Pulmonary Medication Delivery
9. Ivivis PEMF Technology Significantly Improves Neuron Survival in Parkinsons Disease Model, Study Finds
10. Mercks Investigational Migraine Treatment MK-0974 Significantly Improved Migraine Pain on Several Efficacy Measures in a Phase II Study
11. The Eloxatin-Based Regimen (FOLFOX4) Significantly Improved Progression Free Survival When Given Before and After Surgery in Patients With Resectable Liver Metastases From Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... ... , ... June 19, 2016 is World Sickle Cell Observance Day. In an ... of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a ... Cell Disease (SCD) is a disorder of the red blood cells, which can cause ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
(Date:6/24/2016)... San Francisco, CA (PRWEB) , ... June 24, ... ... at CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has ... , self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , ...
Breaking Medicine News(10 mins):