Navigation Links
Bayer and Onyx Initiate Phase 3 Trial of Nexavar in Non-Small Cell Lung Cancer
Date:6/1/2009

WAYNE, N.J. and EMERYVILLE, Calif., June 1 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the companies have begun enrolling patients in an international Phase 3 trial to evaluate Nexavar(R) (sorafenib) tablets in patients with non-squamous non-small cell lung cancer (NSCLC) who have failed two or three previous treatments.

"Nexavar has proven efficacy in liver cancer and kidney cancer and we are committed to researching Nexavar in a variety of other solid tumors," said Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "Based on the results of a signal generating Phase 2 study, Bayer and Onyx initiated this Phase 3 trial to evaluate Nexavar in non-small cell lung cancer."

Phase 3 Trial Design

The MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial, is an international multicenter study that will enroll approximately 850 patients with advanced relapsed or refractory non-squamous NSCLC who have failed two or three previous treatments. Patients will be randomized to receive either Nexavar as single agent or placebo. In both treatment arms, best supportive care will be provided. The primary endpoint of this trial is overall survival, and secondary endpoints include progression-free survival and overall response rate. The safety and tolerability of the two treatment groups will also be compared.

The study will be conducted at more than 120 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan. For information about this study, please visit www.clinicaltrials.gov.

"As the leading cause of cancer deaths worldwide, lung cancer is a complex disease that requires new therapeutic options for patients," said Laura Brege, executive vice president and chief operating officer at Onyx Pharmaceuticals. "We are committed to studying Nexavar to understand how it may play a role in the treatment paradigm of this difficult-to-treat disease."

About Non-Small Cell Lung Cancer (NSCLC)

NSCLC accounts for 85-90 percent of diagnosed lung cancers(1) and is a disease in which malignant (cancer) cells form in the tissues of the lung. It is characterized by several types of lung cancers, each of which grow and spread in different ways, including: squamous cell carcinoma, adenocarcinoma, and large cell carcinoma.(1)

Every year 1.4 million people worldwide will be diagnosed with lung cancer and 1.2 million will die from the disease.(2) Nearly 60 percent of Americans diagnosed with lung cancer die within one year of their diagnosis and 75 percent die within 2 years. These survival rates have not improved in the past 10 years.(3)

Nexavar's Differentiated Mechanism

Nexavar, an oral anti-cancer therapy, is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer. 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.

Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including, breast cancer, colorectal cancer, lung cancer, ovarian cancer, and as an adjuvant therapy for kidney cancer and liver cancer.

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, 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. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% 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 information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar(R) (sorafenib) tablets, a small molecule drug. For more information about Onyx, visit the company's website at www.onyx-pharm.com.

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 our annual and interim reports filed with the Frankfurt Stock Exchange. The company 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, safety, 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, 2008, 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 HealthCare Pharmaceuticals, Inc.

---------------------------------------------------

(1) Non-Small Cell Lung Cancer Detailed Guide from American Cancer Society. Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_7x_Lung_Cancer_-_Non-Small_Cell_Detailed_Guide.asp. Accessed April 9, 2009.

(2) 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 9, 2009.

(3) National Cancer Institute SEER data. Available at: http://seer.cancer.gov/statistics/. Accessed April 9, 2009


'/>"/>
SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. IVCC launches groundbreaking insecticide projects with Bayer and Syngenta
2. AUDIO from Medialink and Bayer: Simple, Focused Ways to Boost Womens Health
3. Bayer HealthCare Cleared to Acquire Citracal(R)
4. Genzyme and Bayer Schering Pharma AG, Germany to Present New Data on Alemtuzumab in Multiple Sclerosis at ECTRIMS
5. Bayer Foundation Grant Creates Graduate Engineering Fellowship at University of Houston
6. AUDIO from Medialink and Bayer: Is Your Pain Reliever Undermining Your Aspirin Therapy?
7. Bayer Temporarily Suspends Global Trasylol(R) Marketing
8. AUDIO from Medialink and Bayer: Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained with Naproxen Sodium
9. Bayer Plants Trees With Chartiers Valley Intermediate School Students, Provides Free Environmental Education Materials
10. Bayer Awards Making Science Make Sense Grant to Girl Scouts
11. Bayer HealthCare Pharmaceuticals and MedAssets Supply Chain Systems Sign a Three-Year Agreement for Magnevist(R) Magnetic Resonance Contrast Media
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2017)... ... 2017 , ... Parker at Stonegate, an assisted living residence ... caregivers, volunteers, thought leaders, researchers, educators and partners leading the way in services ... refresh the carpeting with the goal of maintaining the same precise colors and ...
(Date:8/18/2017)... ... August 18, 2017 , ... More than 20,000 pairs of ... Congo (DRC) thanks to an ambitious venture that conjoined the passions of an NBA ... support of the Liberty community. These shoes will save lives from the rampant infections ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... edition of “Vision & Hearing,” advocating for active, healthy lifestyles and highlighting the ... available for individuals with hearing impairments and shares the latest innovations in hearing ...
(Date:8/18/2017)... ... 2017 , ... Hernandez Insurance Agencies, a northern Virginia firm ... DC region, is inaugurating a “New Leash On Life” charity initiative in conjunction ... to be companions for veterans in need. , The Semper K9 organization works ...
(Date:8/18/2017)... ... August 18, 2017 , ... The Brian Gifford Agency, an ... is campaigning in support of Campagna Academy in a charity drive to provide for ... Boys’ Town of Indiana,” Campagna Academy is a nonprofit organization that has offered critical ...
Breaking Medicine News(10 mins):
(Date:8/15/2017)... Pharmaceuticals Inc., the creator of the drug Truveta for the ... an IPO. The United States spends ... a prescription epilepsy drug being $450.00-$1200.00 for a one month supply. ... AXIUM PHARMACEUTICALS, INC ... figure is the fact that Americans spent $42 billion on anxiety medications ...
(Date:8/10/2017)... Aug. 10, 2017  Physical Rehabilitation Network (PRN), acquired the ... Lakewood, Colorado . The reputable clinic will continue ... PT, DPT with his staff of four clinicians. Lipkin received ... and brings over 10 years of experience with a strong ... Belmar PT marks the 10th PRN clinic in and around the ...
(Date:8/7/2017)... , Aug. 7, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Joel Saban as president, effective Aug. 7, 2017. ... has decided to pursue other interests and will serve as ... tenure, Paul has served us in multiple leadership roles since ... in Jun. 2015 and has provided decisive, strategic leadership which ...
Breaking Medicine Technology: