Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
21 August 2008 - 10:00PM
PR Newswire (US)
WAYNE, N.J. and EMERYVILLE, Calif., Aug. 21 /PRNewswire-FirstCall/
-- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals,
Inc. (NASDAQ:ONXX) today 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. For information about Nexavar including U.S. Nexavar
prescribing information, visit http://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
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.
(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. DATASOURCE: Onyx
Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals, Inc.
CONTACT: Joanne Marlin of Bayer HealthCare Pharmaceuticals,
+1-973-305-5383; or Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-597-6505; or media, Geoff Curtis of WeissComm Partners,
+1-312-550-8138, for Onyx Pharmaceuticals, Inc. Web site:
http://www.onyx-pharm.com/ http://www.bayer.com/
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