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Bayer And Onyx Begin Enrollment In STORM Trial Studying Nexavar As Adjuvant Therapy For Patients With Liver Cancer
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc.
(Nasdaq: ONXX) announced the companies have begun enrolling patients
in the STORM Sorafenib as Adjuvant Treatment in the Prevention of
Recurrence of Hepatocellular Carcinoma trial. The randomized, double-blind,
placebo-controlled Phase 3 study is evaluating Nexavar(R) (sorafenib)
tablets as adjuvant treatment, which is treatment following surgery or
local radiation, for patients with hepatocellular carcinoma (HCC), or
primary liver cancer.
"Nexavar is the only systemic therapy with proven efficacy and
tolerability in HCC across multiple patient populations," said Dimitris
Voliotis, MD, vice president, Nexavar Clinical Development, Bayer
HealthCare Pharmaceuticals. "Liver cancer is the third largest global
cancer killer worldwide and there is a significant need for new therapies
that can be used at all stages in the course of the disease to delay
disease progression and prolong life."
In addition, the U.S. Food and Drug Administration (FDA) has completed
a Special Protocol Assessment (SPA) for the STORM trial. An SPA is a
written agreement on the design and size of a clinical trial intended to
form the basis for a new drug application.
Phase 3 Trial Design
The international multicenter study is expected to enroll approximately
1,100 patients and will include patients who have received surgical
resection or local ablation. The study will look at whether providing oral
Nexavar in the adjuvant setting delays the time to recurrence and increases
overall survival. The primary endpoint of the study is recurrence 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 will
be randomized to receive 400 mg of Nexavar twice daily or matching placebo
for up to four years. The study will be conducted at more than 200 sites in
North America, South America, Europe and the Asia-Pacific region, including
Japan. For information about enrolling in the study, please visit
http://www.clinicaltrials.gov.
Hepatocellular carcinoma is the most common form of liver cancer and is
responsible for about 90 percent of the primary malignant liver tumors in
adults. Liver cancer is the sixth most common cancer in the world and the
third leading cause of cancer-related deaths globally. More than 600,000
cases of liver cancer are diagnosed worldwide each year (more than 400,000
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 approximately
370,000 in China, South Korea and Japan, 57,000 in the European Union, and
13,000 in the United States.(1,2)
Currently there are no adjuvant treatments with proven benefit in HCC
and half of the patients who have undergone surgical resection or local
ablation will see their tumors return within three years and 70 percent
will see their tumors return within five years.(3)
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.
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. 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 metastatic melanoma, lung cancer, breast cancer and as
an adjuvant therapy for kidney 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.
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 http://www.onyx-pharm.com.
Forward Looking Statements
This news release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer Group or subgroup
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 which are available on the Bayer Web site at
http://www.bayer.com. 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 results of
the clinical development, safety, regulatory processes, commercialization
efforts or commercial potential 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, 2007,
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.
References
(1) 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 May 2008.
(2) 2005 Cancer Register System (CRS) annual report,
http://crs.cph.ntu.edu.tw/crs_c/annual.html. Accessed May 12, 2008.
(3) Del Pozo AC, Lopez P. Management of hepatocellular carcinoma. Clin
Liver Dis 2007 May;11(2):305-21.
Onyx Pharmaceuticals, Inc
http://www.onyx-pharm.com
View drug information on Nexavar.
Bayer ªi Onyx Inceput de înscriere În FURTUNÃ Trial Studiu Nexavar Ca Tratamentul adjuvant la pacienþii cu Ficat de Cancer - Bayer And Onyx Begin Enrollment In STORM Trial Studying Nexavar As Adjuvant Therapy For Patients With Liver Cancer - articole medicale engleza - startsanatate