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 - 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

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

Web site:

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:
(Date:11/26/2015)... 26, 2015 ... adds "Global Repaglinide Industry 2015 ... on China Repaglinide Market, 2010-2019" reports ... and information to its online business ... . --> ...
(Date:11/25/2015)... 25, 2015 ... the "Global Brain Monitoring Devices Market ... --> ) has announced the ... Devices Market 2015-2019" report to their ... ( ) has announced the addition ...
(Date:11/25/2015)... AAIPharma Services Corp./Cambridge Major Laboratories, Inc. ... $15.8  Million to expand its laboratories and global ... The expansion will provide additional office space and ... of the pharmaceutical and biotechnology markets. ... up to 40,000 square feet of expanded development ...
Breaking Medicine Technology:
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... Lizzie’s Lice ... The company is offering customers 10% off of their purchase of lice treatment product. ... at full price. According to a company spokesperson. “Finding lice is a sure way ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community ... 30 (see Table 1-1 ). More than 3.7 billion people under the age ... type 1 (HSV-1), according to WHO's first global estimates of HSV-1 infection . , ...
(Date:11/27/2015)... ... 27, 2015 , ... A simply groundbreaking television series, "Voices in America", which ... into an array of issues that are presently affecting Americans. Dedicated to providing the ... show is changing the subjects consumers focus on, one episode at a time. ...
(Date:11/27/2015)... Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic ... list of CAAHEP accredited colleges, as only one of twelve colleges and universities in ...
(Date:11/27/2015)... ... 27, 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces ... This is one of Joplin's most famous and beautiful concert posters. The concert was ... in Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's ...
Breaking Medicine News(10 mins):