�Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. announced the start of a Phase III study with Nexavar� (sorafenib) tablets in liver cancer. The randomized, double blind, placebo-controlled study is evaluating Nexavar as an adjuvant therapy for patients with hepatocellular carcinoma (HCC), or primary liver cancer. An adjuvant handling is minded as an additional systemic therapy after the initial tumor treatment, e.g. surgery, to fight crab cells that may have spread.
The STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial aims to further build on earlier Phase III information, which demonstrated a substantial improvement in overall survival in patients with unresectable liver cancer. Based on the strong suit of these data, Nexavar was approved for HCC in the U.S. and Europe at the death of 2007.
"Nexavar is the only systemic therapy with proven efficaciousness and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, MD, Vice President, Nexavar Clinical Development, Bayer HealthCare. "Liver cancer is the one-third largest planetary cause of cancer-related deaths worldwide and there is a meaning need for new therapies that bathroom be secondhand at all stages in the grade of the disease to delay advance and keep up life."
In addition, the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the trial. An SPA is a written agreement between the FDA and the company that the excogitation and size of a clinical test are satisfactory to support a New Drug Application for merchandising in the United States.
About the Phase III Study
Currently thither are no adjuvant treatments with proved benefit in HCC. The international multicenter study is expected to enroll about 1,one C patients and will admit patients world Health Organization previously received surgery or other procedures to remove their tumor. The study will look at whether providing oral Nexavar in the appurtenant setting delays the time to return and increases overall survival. The chief endpoint of the study is return free survival.
Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.
The study is enrolling patients with all HCC histologies. Patients volition be randomised to receive 400 mg of oral Nexavar doubly daily or matching placebo for up to four-spot years. The study testament be conducted at more than two hundred sites in North America, South America, Europe and the Asia-Pacific region. For information just about enrolling in the study, please visit www.clinicaltrials.gov.
About Hepatocellular Carcinoma
Hepatocellular carcinoma is the most common pattern of liver cancer and is responsible for about 90 pct of the primary malignant liver tumors in adults. Liver cancer is the sixth to the highest degree common cancer in the world and the third leading suit of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than four hundred,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including close to 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States.
About Nexavar�
Nexavar� targets both the tumor cell and neoplasm vasculature. In preclinical studies, Nexavar has been shown to butt members of two classes of kinases known to be byzantine in both cell proliferation (growth) and angiogenesis (blood supply) two important processes that enable cancer emergence. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 40 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who take in failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also being evaluated by the companies, international field groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including metastatic malignant melanoma, lung cancer, breast crab and as an adjuvant therapy for kidney cancer.
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 development and marketing Nexavar� (sorafenib) tablets, a small molecule drug. For more information about Onyx, visit the company's website at http://www.onyx-pharm.com.
About Bayer HealthCare
The Bayer Group is a spherical enterprise with core competencies in the fields of health tending, nutrition and high-tech materials. Bayer HealthCare, a subordinate of Bayer AG, is one of the world's leading, innovative companies in the healthcare and aesculapian 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 business operates under the name Bayer Schering Pharma. Bayer HealthCare's purport is to discover and manufacture products that will improve human and animate being health world-wide. Find more information at http://www.bayerhealthcare.com.
Bayer Schering Pharma is a ecumenical leading specialization pharmaceutical company. Its research and business activities ar focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovational products, Bayer Schering Pharma aims for leading positions in specialized markets global. Using young ideas, Bayer Schering Pharma aims to make a contribution to medical advancement and strives to meliorate the quality of life. Find more information at http://www.bayerscheringpharma.de.
Forward Looking Statements
This release crataegus oxycantha contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and former factors could lead to material differences between the actual future results, fiscal situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer internet site at web.bayer.com. The company assumes no liability any to update these forward-looking statements or to conform them to future events or developments.
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Tuesday, 2 September 2008
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