Study Shows ixabepilone Demonstrated Clear Activity in Patients With Metastatic Breast Cancer Resistant to anthracycline, taxane, and capecitabine


NEW YORK, July 6 /PRNewswire/ --

- Phase II Results Published in the Journal of Clinical Oncology

- Not for Publication in the Following Countries: Germany, France, UK and
Scandinavia

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 (NYSE:BMY) 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, progression-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 19th, the company announced that the U.S. Food and Drug
Administration (FDA) has accepted, for filing and granted priority review of,
these data as part of the New Drug Application (NDA) 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 result of new
information, future events or otherwise.

NEW YORK, July 6 /PRNewswire/ --

© PR Newswire Association LLC.

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