Facet Biotech Corporation (Nasdaq: FACT) and Bristol-Myers
Squibb Company (NYSE: BMY) announced that potentially promising
data from a Phase I/II study of elotuzumab, an investigational
humanized antibody being studied for the treatment of relapsed
multiple myeloma (MM), were presented today at the American Society
of Hematology (ASH) 2009 Annual Meeting in New Orleans.
The ongoing Phase I/II study of elotuzumab plus lenalidomide and
low-dose dexamethasone evaluated multiple doses of elotuzumab in
patients with multiple myeloma. The interim results given as an
oral presentation today showed that of the 28 treated patients in
the trial, 23 (82 percent) had an objective response (OR) by
International Myeloma Working Group (IMWG) criteria. A subset
analysis showed that of 22 patients who had not previously received
lenalidomide treatment, 21 patients (95 percent) achieved an
OR.
No dose-limiting toxicities (DLT) were reported in the study up
to the highest dose level of 20 mg/kg and a maximum-tolerated dose
(MTD) was not established. Two patients experienced serious adverse
events of allergic reactions that were related to elotuzumab and
were withdrawn from the study. These adverse events resolved with
treatment. In addition, other adverse events reported for the
combination of lenalidomide, dexamethasone and elotuzumab,
regardless of causality to disease or study drugs, included
fatigue, diarrhea, constipation, myelosupression, nausea, muscle
spasms, fever, chills and dyspnea. Enrollment for the Phase I
portion of the study is completed.
“The preliminary data presented today show that elotuzumab in
combination with lenalidomide and dexamethasone may have potential
as a treatment option for patients with multiple myeloma,” said
Faheem Hasnain, president and chief executive officer of Facet
Biotech. “We are working closely with our partners at Bristol-Myers
Squibb to finalize next steps for the elotuzumab development
program, and anticipate initiating a global Phase II study in the
first half of 2010.”
“We, along with our partner, Facet Biotech, are focusing on the
investigation of combinations of potential treatments in the hopes
of identifying a more efficacious and tolerable option for patients
to help them when faced with this serious disease,” said Brian
Daniels, M.D., senior vice president, Global Development &
Medical Affairs, Bristol-Myers Squibb.
“These interim results are of significant scientific and
clinical interest. I am very encouraged by the efficacy and safety
data seen to date for this combination, which may offer a future
treatment option for multiple myeloma patients,” said Sagar Lonial,
M.D., of the Winship Cancer Institute at Emory University in
Atlanta. “Given that elotuzumab, a humanized antibody, has a novel
mechanism of action that appears to work synergistically with
lenalidomide, we look forward to advancing clinical studies with
this antibody to determine its full potential, with the goal of
ultimately improving outcomes for myeloma patients.”
The primary objective of the Phase I/II study is to evaluate the
maximum tolerated dose (MTD) of elotuzumab in combination with
lenalidomide and low dose dexamethasone in patients with relapsed
MM. The study is also evaluating safety, pharmacokinetics (PK) and
clinical response. Elotuzumab in three escalating dose cohorts (5,
10 and 20 mg/kg) is administered by IV infusion.
Interim results from another Phase I/II study were also
presented today at the ASH annual meeting. In a study of elotuzumab
plus bortezomib in 20 evaluable patients, eight patients, 40
percent, had an OR and 60 percent achieved a clinical response,
defined as minimal response or better using the combined European
Group for Blood and Marrow Transplant (EBMT) and IMWG criteria. No
DLTs were reported and an MTD was not established. The study
continues to enroll patients at the 20 mg/kg dose level.
About Elotuzumab
Elotuzumab is a humanized monoclonal antibody directed against
CS1, a cell-surface glycoprotein that is highly and uniformly
expressed on multiple myeloma cells but is minimally expressed on
normal cells. In nonclinical studies, elotuzumab has been shown to
induce antibody-dependent cellular cytotoxicity (ADCC) against
primary myeloma cells and is currently in Phase I/II clinical
development.
About Facet Biotech
Facet Biotech is a biotechnology company dedicated to advancing
its pipeline of five clinical-stage products, leveraging its
research and development capabilities to identify and develop new
oncology drugs and applying its proprietary next-generation protein
engineering technologies to potentially improve the clinical
performance of protein therapeutics.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company
committed to discovering, developing and delivering innovative
medicines that help patients prevail over serious diseases. For
more information, please visit www.bms.com.
Facet Biotech Forward Looking Statements
This press release contains forward-looking statements,
including regarding Facet Biotech’s and Bristol-Myers Squibb’s
development of elotuzumab and the anticipated initiation of a
global Phase II study in the first half of 2010. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from those, express or implied, in
these forward-looking statements. Many factors may cause
differences between current expectations and actual results. For
example, the development of elotuzumab could be adversely impacted
by changes in Facet Biotech’s and Bristol-Myers Squibb’s
development plans or timelines, including because of unexpected
safety or efficacy data observed during clinical trials, enrollment
rates in clinical trials, difficulties in supplying clinical sites
with study drugs and changes in expected competition. As a result,
the Phase II trial of elotuzumab may not be initiated by the first
half of 2010 or at all. The results observed to date in clinical
trials of elotuzumab may not be predictive of results to be
obtained in the additional evaluations and studies that would be
necessary to demonstrate elotuzumab to be effective in the
treatment of patients with MM with an acceptable safety profile.
Other factors that may cause Facet Biotech’s actual results to
differ materially from those expressed or implied in the
forward-looking statements in this press release are discussed in
Facet Biotech’s filings with the SEC, including the “Risk Factors”
sections of the Company’s periodic reports on Form 10-K and Form
10-Q filed with the SEC. Copies of Facet Biotech’s filings with the
SEC may be obtained at the “Investors” section of Facet Biotech’s
website at www.facetbiotech.com. Facet Biotech expressly disclaims
any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Facet Biotech’s expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statements are based for any reason, except as
required by law, even as new information becomes available or other
events occur in the future. All forward-looking statements in this
press release are qualified in their entirety by this cautionary
statement.
Bristol-Myers Squibb Forward-Looking Statements
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995, regarding the research, development and commercialization of
pharmaceutical products. 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 compound described in this release will move from early
stage development into full product development, that clinical
trials of this compound will support a regulatory filing, or that
the compound will receive regulatory approval or become a
commercially successful product. Forward-looking statements in the
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, 2008, its Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events, or
otherwise.
NOTE: Facet Biotech and the Facet Biotech logo are considered
trademarks of Facet Biotech Corporation.
Facet Biotech (MM) (NASDAQ:FACT)
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Facet Biotech (MM) (NASDAQ:FACT)
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