Navigation Links
Study Shows Ixabepilone Demonstrated Clear Activity in Patients,with Metastatic Breast Cancer Resistant to Anthracycline, Taxane,,and Capecitabine

- Phase II Results Published in the Journal of Clinical Oncology -

NEW YORK, July 06, 2007 /PRNewswire-FirstCall/ -- Results from a Phase II study - which will be published in the August 10, 2007 issue of the Journal of Clinical Oncology (JCO) and are now available as an Early Release Article at www.jco.org - demonstrate that ixabepilone, a Bristol-Myers Squibb Company investigational compound, has activity in patients with metastatic breast cancer whose tumors were resistant to three types of standard chemotherapy (anthracycline, taxane, and capecitabine). Currently, there are few proven treatment options available to patients with breast cancer whose disease has rapidly progressed through or whose disease is not responding to prior treatment with approved chemotherapies. This study was one of five Phase II ixabepilone studies published in this issue of JCO, including three additional studies in metastatic breast cancer and one in non-small cell lung cancer.

"Drug resistance is a major concern in treating patients with advanced disease," said Renzo Canetta, vice president, Oncology Global Clinical Research, Bristol-Myers Squibb. "The results of this study are important as they provide valuable information about this investigational compound and its potential in patients with advanced breast cancer that is no longer responding to any of the current U.S. approved chemotherapy treatments."

The 126 patients enrolled in the single-arm Phase II study (CA163081) had heavily pretreated, advanced metastatic breast cancer, which had progressed through three prior therapies (anthracycline, taxane and capecitabine). The primary endpoint was objective response rate, which is an assessment of the response to treatment as determined by the independent radiology facility (IRF). Secondary efficacy endpoints included duration of response, time to response, progres sion-free survival (PFS), and overall survival (OS), and with the exception of OS, analyses were based on IRF data. Response-evaluable patients were defined as patients with measurable disease, as determined by the IRF, which met the resistance criteria for anthracyclines, taxanes, and capecitabine. Results of the 113 response-evaluable patients were assessed by the IRF, as well as independently by investigators at the study site, and showed:

    -- Objective response rate was achieved in 11.5% of patients as determined

       by the IRF and 18.6% as determined by the investigators.

    -- Median duration of response of 5.7 months.

    -- Median time to response of 6.1 weeks.

    -- Median progression-free survival of 3.1 months.

    -- Median overall survival of 8.6 months.

Overall treatment-related non-hematological adverse events greater than or equal to 20% included: peripheral sensory neuropathy 60% (Grade 3/4: 14%); fatigue/asthenia 50% (Grade 3/4: 14%); myalgia/arthralgia 49% (Grade 3/4: 8%); alopecia 48% (Grade 3/4: 0%); nausea 42% (Grade 3/4: 2%); stomatitis/mucositis 29% (Grade 3/4: 7%); vomiting 29% (Grade 3/4: 1%); diarrhea 22% (Grade 3/4: 1%); and musculoskeletal pain 20% (Grade 3/4: 3%). Treatment-related hematological adverse events greater than or equal to 20% included: leukopenia 90% (Grade 3/4: 49%); anemia 84% (Grade 3/4: 8%); neutropenia 79% (Grade 3/4: 54%); and thrombocytopenia 44% (Grade 3/4: 8%).

About Ixabepilone

Ixabepilone is an investigational compound, a semisynthetic analog of epothilone B, designed to inhibit or prevent the growth or development of cancer cells. Epothilones are a potential new class of antineoplastic (or chemotherapy) agents. For information on ixabepilone clinical trials, log on to www.clinicaltrials.gov.

On June 19, 2007 the company announced that the U.S. Food and Drug Administration has accepted, for filing and granted priority review of, these data as part of the New Drug Application for ixabepilone. The target action date is in late October. The proposed indications for ixabepilone are as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane. The company also plans to submit these data as part of a registrational dossier in the European Union, and other countries this year.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the application submitted to the FDA will be approved, that an application will be submitted or approved in any other country, or, if approved, that the product will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a resu lt of new information, future events or otherwise.

CONTACT: Media, Madeline Malia, Media Communications, +1-609-252-3347office, +1-609-651-1323 mobile, , or Jeff Macdonald,Media Communications, +1-917-371-0940 mobile, , orInvestors, John Elicker, Investor Relations, +1-212-546-3775,, all of Bristol-Myers Squibb madeline.malia@bms.com jeffrey.macdonald@bms.com john.elicker@bms.com

Web site: http://www.bms.com/http://www.jco.org/http://www.clinicaltrials.gov/

Ticker Symbol: (NYSE:BMY)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
8. Protox Announces Positive Clinical Data from Prostate Cancer Study
9. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
10. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
11. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/8/2017)... Fla. , June 8, 2017  Less than ... that hit more than 200,000 companies, including hospital networks, ... being heralded as one of the largest online extortion ... in the healthcare market, it is imperative that providers ... protect their data from this — and many other ...
(Date:6/7/2017)... 2017  Diplomat Specialty Infusion Group, a brand of Diplomat Pharmacy, ... Iowa location. The ... features an ISO 7 cleanroom—the standard needed to compound intravenous (IV) ... level of pollutants. "Our new ... better serve our Iowa patients," said ...
(Date:6/1/2017)... BLUE BELL, Pa. , June 1, 2017 /PRNewswire/ ... Nutriceuticals (PRN) and Veterinarian Recommended Solutions (VRS), and KD ... direct investment in Nutriceutical Holdings by KD Pharma Group. ... Nutriceutical Holdings with the option to acquire the entire ... ideal partner in KD. They are committed to growing ...
Breaking Medicine Technology:
(Date:6/24/2017)... ... June 24, 2017 , ... ... Located at 217 Portion Road in Lake Ronkonkoma, Dental365 offers patients high-quality and ... so that visits to the dentist fit into their patients’ busy lifestyles. Dental365 ...
(Date:6/23/2017)... ... June 23, 2017 , ... ... the launch of Care Management Alerts and Dashboards, an innovative new service enabling ... Island. , RIQI’s Care Management Alerts and Dashboards provide near real-time data about ...
(Date:6/23/2017)... ... 2017 , ... Yesterday, U.S. Senate Republicans revealed details of ... replace the Affordable Care Act (ACA). Like the bill narrowly passed by the ... public health insurance program for low-income children, pregnant women, parents of dependent children, ...
(Date:6/23/2017)... ... 2017 , ... Dr. Ran Y. Rubinstein , a ... offering three new minimally invasive procedures to patients who want a younger and ... Rubinstein is excited to bring microneedling, microneedling facials, and platelet rich plasma (PRP) ...
(Date:6/23/2017)... ... ... Goodcents Deli Fresh Subs today announced the opening of a new restaurant in ... Kan. 66604 (near 21st and Gage). It is owned and operated by long-time Goodcents ... the Topeka and Bonner Springs, Kan. area. , “Goodcents has such a loyal ...
Breaking Medicine News(10 mins):