Navigation Links
Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
Date:8/21/2008

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, ti
'/>"/>

SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCarePharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) to Hold Conference Call to Discuss Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data
2. Bayer HealthCare Celebrates 20th Anniversary of Kogenate(R) Product Line and 8 Billion IU Milestone at 2008 WFH World Congress
3. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis
6. Genzyme and Isis Begin Second Phase 3 Trial Of Mipomersen
7. Light Sciences Oncology Begins Clinical Trials of Litx Therapy in Patients with Enlarged Prostate
8. Catalyst Pharmaceutical Partners, Inc. Begins Enrollment for U.S. Phase II Clinical Trial of CPP-109 in Patients with Methamphetamine Addiction
9. Micromet and Nycomed Begin Formal Preclinical Safety Studies for Antibody MT203 for Inflammatory and Autoimmune Diseases
10. Champions Biotechnology Begins Preclinical Development of Its Lead Oncology Drug Candidate
11. European Enrollment Begins in Pivotal Phase 3 Trial of Novel Combination Medicine Developed by Cogentus Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014 AARP Foundation today announced it ... adults suffering from the severe cold weather that has gripped ... to helping those in need; so to support these emergency ... up to $250,000, which could mean up to $500,000 in ...
(Date:1/15/2014)... Jan. 15, 2014 Massachusetts General Hospital (MGH), ... AMGN ) announced today that they have launched ... new therapeutic targets and develop novel therapies for ... affects millions worldwide. The MGH-Broad-Amgen collaboration brings together ...
(Date:1/15/2014)... , January 15, 2014 BreedIT Corp ... exclusive worldwide distributor of highly sophisticated agro-breeding solutions for ... 7, 2014, the Company,s board of directors appointed chemistry ... as its new member of the board. ...
Breaking Medicine Technology:AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 2AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3
... LigoCyte Pharmaceuticals, Inc. , a private, clinical-stage ... vaccine products, announced today that it has initiated ... (IM) norovirus vaccine candidate, marking the fourth human ... (VLP) vaccine program.  The Phase I dose-escalation study ...
... Top researchers at the Gastrointestinal Cancer Research Lab at ... clinical applications of BCM-95®, a new patented extract of ... Previous studies have shown that BCM-95 curcumin was 7-10 ... had a retention time in the bloodstream between 8 ...
Cached Medicine Technology:LigoCyte Pharmaceuticals Initiates First Clinical Trial for Bivalent Intramuscular Norovirus Vaccine 2LigoCyte Pharmaceuticals Initiates First Clinical Trial for Bivalent Intramuscular Norovirus Vaccine 3BCM-95 Demonstrates Superior Anti-Inflammatory Effects 2
(Date:4/18/2014)... A new study in the American Journal of ... searches reveals a recurring pattern that could be leveraged ... from San Diego State University, the Santa Fe Institute, ... Google searches (searches that included the term healthy and ... U.S. from 2005 to 2012. They found that on ...
(Date:4/17/2014)... inflammation in non-cancerous prostate tissue may have nearly twice ... with no inflammation, according to results of a new ... Cancer Center. , The link between persistent inflammation and ... prostate cancer those with a Gleason score between ... most aggressive and rapidly growing prostate cancers. , "What ...
(Date:4/17/2014)... PLOS Pathogens , children who live in regions ... an immune response to infection with malaria parasites that ... fever and illness and partially control the growth of ... researchers develop future interventions that prevent or mitigate the ... approximately 200 million cases of malaria occur worldwide, resulting ...
(Date:4/17/2014)... In a review published in the April issue ... of The Feinstein Institute for Medical Research, says it,s ... community,s approach to treating sepsis, which kills ... , Sepsis occurs when molecules released into the bloodstream ... the body. Inflammation is necessary for maintaining good health ...
(Date:4/17/2014)... (April 17, 2014) Doctors who treat patients ... lymphangioleiomyomatosis (LAM) can face an agonizing treatment decision. ... the disease and help relieve shortness of breath. ... and sirolimus can cause potentially fatal complications following ... Dr. Daniel Dilling, medical director of Loyola University ...
Breaking Medicine News(10 mins):Health News:New research shows people are thinking about their health early in the week 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Study sheds light on how the immune system protects children from malaria 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3
... Walter and Eliza Hall Institute scientists have revealed ... in the immune system, identifying in the process ... disorders. Dr Jeff Babon and Professor Nick ... and Haematology divisions respectively, study interactions between internal ...
... wallpaper-like liner help reduce the number of cases of malaria, ... Shepard, a professor at the Schneider Institutes for Health Policy ... gotten the Bill and Melinda Gates Foundation to help. A ... allow Shepard and collaborators to pursue their research in Kenya ...
... , THURSDAY, Feb. 16 (HealthDay News) -- Researchers have sequenced ... and the transmissible facial cancer that threatens the species with ... meat-eating marsupials found only on the Australian island of Tasmania, ... the journal Cell . "There are targeted drugs ...
... , WEDNESDAY, Feb. 15 (HealthDay News) -- Researchers have discovered ... of cases of inherited dilated cardiomyopathy, a serious heart muscle ... In the study, published in the Feb. 16 issue ... analyzed the DNA of 312 people with dilated cardiomyopathy, 231 ...
... parent-training program is effective in reducing the risk of low-income, ... found that after one year, there was a 9 percent ... group, while a control group that did not receive the ... obese children. "This is the first ...
... Reporter , WEDNESDAY, Feb. 15 (HealthDay News) -- Researchers report ... kicking off puberty in humans, a finding that offers insight ... who suffer from a rare disease that prevents the start ... family whose members have suffered from the disease confirmed that ...
Cached Medicine News:Health News:Cell signaling discovery provides new hope for blood disorders 2Health News:Gates Foundation awards grant to tackle malaria 2Health News:Genome Map Might Help Save Tasmanian Devil From Extinction 2Health News:Study Finds Gene Behind Inherited Cases of Enlarged Heart 2Health News:Study Finds Gene Behind Inherited Cases of Enlarged Heart 3Health News:Parent-training intervention curbs pediatric obesity rates, study shows 2Health News:Parent-training intervention curbs pediatric obesity rates, study shows 3Health News:Gene Linked to Start of Puberty 2