Navigation Links
Global Phase III Study Results Show Eribulin Meets Primary Endpoint of Overall Survival
Date:10/30/2009

WOODCLIFF LAKE, N.J., Oct. 30 /PRNewswire/ -- Eisai Inc. today announced preliminary results from a recently completed Phase III study with eribulin mesylate (E7389), discovered and developed by the company, in patients with locally advanced or metastatic breast cancer.

This global Phase III study, known as "EMBRACE," (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), was an open-label, randomized, parallel two-arm, multi-center study of 762 women with locally recurrent or metastatic breast cancer previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane.

The patients were treated either with eribulin (administered intravenously over two to five minutes on days 1 and 8 every 21 days) or with treatment of physician's choice. Treatment of physician's choice is defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice.

Preliminary results from the study demonstrated a statistically significant improvement in overall survival, the primary endpoint, in eribulin-treated patients compared with the physician's choice of therapy. The safety profile of eribulin in this Phase III study was consistent with the adverse events seen in previous Phase II clinical studies and the most common adverse event reported was myelosuppression.

Eribulin is a new chemical compound discovered and developed by Eisai. It is a synthetic analogue of halichondrin B, a naturally-derived compound that was first isolated from a marine sponge. While taxanes inhibit cell division by stabilizing microtubules, eribulin is a microtubule dynamics inhibitor that arrests the cell cycle through inhibition of the growth of microtubules without interfering with microtubule shortening.

While early detection by breast cancer screening and the development of innovative anti-cancer drugs have contributed to the decline in breast cancer mortality around the world, breast cancer remains one of the leading causes of cancer death in women. Although advances are being made every year in the treatment of breast cancer, women with locally advanced or metastatic breast cancer have limited treatment options and the development of more effective treatment or anti-cancer drugs is critically important. It is believed that more than one million women are newly diagnosed with breast cancer each year around the world.

Eisai will complete a more detailed analysis of the data prior to submitting marketing authorization applications for eribulin to health authorities in Japan, the United States, and Europe for locally advanced and metastatic breast cancer by the end of the fiscal year 2009.

Eisai is currently conducting clinical trials of this compound in-house to evaluate the efficacy and safety not only in breast cancer, but also in non-small cell lung cancer (NSCLC), hormone refractory prostate cancer, and sarcoma. Eisai also includes eribulin as one of the compounds in the co-development projects based on the strategic collaboration agreement with Quintiles and will proceed with joint clinical development of this compound for NSCLC as well as bladder cancer.

Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai will make further contributions to addressing the diversified needs of and improving benefits to patients and families affected by cancer as well as healthcare professionals.

For more information about eribulin, U.S. health care professionals and patients may call 1-877-220-3921.

Eisai Inc.

Eisai Inc. is a wholly-owned subsidiary of Eisai Corporation of North America.

Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), the company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2008 (year ended March 31, 2009) sales of approximately $3.7 billion. Eisai Inc.'s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Headquartered in Woodcliff Lake, New Jersey, Eisai Inc. has several R&D facilities in Massachusetts, New Jersey and North Carolina, as well as manufacturing facilities in Maryland and North Carolina. For more information about Eisai, please visit www.eisai.com.

*On October 1, 2009, Eisai Research Institute of Boston, Inc. (established in 1987) and Eisai Medical Research Inc. (established in 2002) were merged into Eisai Inc.

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.

Eisai concentrates its R&D activities in three key areas:

  • Integrative Neuroscience, including Alzheimer's disease, neuropathic pain and epilepsy.
  • Integrative Oncology, including anticancer therapies, tumor regression, tumor suppression and antibodies; supportive cancer therapies include nausea and vomiting.
  • Vascular/Immunological Reaction including acute coronary syndrome, atherothrombotic disease and sepsis.

SOURCE Eisai Inc.


'/>"/>
SOURCE Eisai Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Public-Private Partnerships Key to Achieving Global Food Security, Says DuPont Leader
2. Reportlinker Adds Global Top 10 Biotechnology Companies -- Industry, Financial and SWOT Analysis
3. Global Med Technologies(R), Inc. Licenses EdgeLab to Seven Laboratories at University Hospital of Reims, France
4. Global Bioenergies is Setting-Up its Scientific Advisory Board and Obtains Proof of Concept for a Bioprocess Generating Gaseous Hydrocarbons From Renewable Resources
5. Systagenix Announces Formation of New Global Medical Advisory Board to Support Future Clinical Advances in Wound Care
6. Global Pharmaceutical Company Awards Comprehensive Cardiac Safety Study to iCardiac
7. Biotechnology Can Address Global Mega Trends, DuPont Leader Says
8. Environmental & Economic Factors Drives Global Demand for Pharmaceutical leak Testing and Deblistering
9. Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
10. Global Biofuels Growth to Double by 2015
11. DIA Conference to Provide FDA, EMEA, Health Canada, Emerging Regions, NGO, and Industry Perspectives on Global Vaccine Development
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2017)... ... August 21, 2017 , ... Today Aether announced that Aether and ... a Bill and Melinda Gates Foundation grant, to pursue a 3D ... Foundation, also known as the Gates Foundation, is said to be the largest transparently ...
(Date:8/17/2017)... ... 17, 2017 , ... Cynvenio Biosystems, Inc., a leader in ... of a new breast cancer monitoring study in partnership with Saint Luke’s Cancer ... for early detection of recurrent breast cancer using LiquidBiopsy and natural killer (NK) ...
(Date:8/16/2017)... ... August 16, 2017 , ... While art and science are often thought ... than one might think. A Mesh Is Also a Snare, a group exhibition ... Science Center’s Esther Klein Gallery (EKG) on August 17 and run through September 30. ...
(Date:8/16/2017)... , Aug. 16, 2017  Kingfisher Talent, the ... leadership development, and Virdis Group, global executive search specialists in ... that enables clients to leverage the expertise and reach of ... clients here in the Boston biotech ... of leadership talent throughout the US, Canada ...
Breaking Biology Technology:
(Date:3/27/2017)... CENTRE, N.Y. , March 27, 2017 /PRNewswire-USNewswire/ ... Healthcare Information and Management Systems Society (HIMSS) Analytics ... Outpatient EMR Adoption Model sm . In addition, ... 12% of U.S. hospitals using an electronic medical ... CHS for its high level of EMR usage ...
(Date:3/24/2017)... -- Research and Markets has announced the addition of ... - Industry Forecast to 2025" report to their offering. ... The Global Biometric Vehicle ... around 15.1% over the next decade to reach approximately $1,580 million ... estimates and forecasts for all the given segments on global as ...
(Date:3/23/2017)... DUBLIN , Mar. 23, 2017 Research ... Anti-Theft System Market Analysis & Trends - Industry Forecast to 2025" ... ... to grow at a CAGR of around 8.8% over the next ... This industry report analyzes the market estimates and forecasts for all ...
Breaking Biology News(10 mins):