Acceleron Pharma Outlines Corporate Objectives for 2015
12 Enero 2015 - 6:00AM
Business Wire
– Phase 3 Clinical Trials in both MDS and
Beta-Thalassemia Planned for 2015 –
Acceleron Pharma Inc. (NASDAQ:XLRN), a biopharmaceutical company
focused on the discovery, development and commercialization of
novel protein therapeutics for cancer and rare diseases, today
announced its major corporate research and development objectives
for 2015. Acceleron has four internally discovered and developed
investigational protein therapeutics in human clinical trials and
expects all four molecules to be in either phase 2 or phase 3
clinical trials by the end of 2015.
“Acceleron is pioneering the discovery and development of
protein therapeutics that unlock the body’s ability to build and
repair cells and tissues, and we look forward to advancing all four
of our innovative protein therapeutics into mid- and late-stage
clinical trials this year,” said John Knopf, Ph.D., Chief Executive
Officer of Acceleron.
The major research and development objectives are highlighted
below:
Sotatercept and Luspatercept in Rare Blood Disorders
- Complete phase 2 clinical trials of
luspatercept and sotatercept in MDS and beta-thalassemia
- Finalize phase 3 clinical development
plans with health authorities for MDS and beta-thalassemia
- Initiate phase 3 clinical trials in
MDS
- Initiate phase 3 clinical trials in
beta-thalassemia
Sotatercept in End-stage Renal Disease
- Initiate randomized, controlled stage
of phase 2b clinical trial of sotatercept in end-stage renal
disease patients
Dalantercept in Advanced Cancers
- Announce top line data from phase 2
trial of dalantercept with axitinib in renal cell carcinoma
- Demonstrate safety of combination of
dalantercept and sorafenib in hepatocellular carcinoma
ACE-083 in Muscle Disorders
- Initiate phase 2 trial with novel
muscle agent ACE-083
Pipeline Expansion
- Conduct IND-enabling work to advance at
least one new protein therapeutic to the clinic in 2016
A slide presentation describing these research and development
goals and other information is available on the "Events and
Presentations" page in the Investors & Media section on the
Company's website
(http://investor.acceleronpharma.com/events.cfm)
About Acceleron
Acceleron is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of novel
protein therapeutics for cancer and rare diseases. The company is a
leader in understanding the biology of the Transforming Growth
Factor-Beta (TGF-β) protein superfamily, a large and diverse group
of molecules that are key regulators in the growth and repair of
tissues throughout the human body, and in targeting these pathways
to develop important new medicines. Acceleron has built a highly
productive R&D platform that has generated innovative clinical
and preclinical protein therapeutic candidates with novel
mechanisms of action. These protein therapeutic candidates have the
potential to significantly improve clinical outcomes for patients
with cancer and rare diseases.
For more information, please visit www.acceleronpharma.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements about the
Company’s strategy, future plans and prospects, including
statements regarding the development of the Company’s compounds,
including sotatercept, luspatercept, dalantercept, or ACE-083 and
the Company’s TGF-β superfamily program generally, the timeline for
clinical development and regulatory approval of the Company’s
compounds, the expected timing for the reporting of data from
ongoing trials, and the structure of the Company’s planned or
pending clinical trials. The words “anticipate,” “appear,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statement. Applicable risks and
uncertainties include the risks that the Company will not achieve
one or more, or any, of the research and development objectives
highlighted above, that the Company’s cash position will be
insufficient to fund operations into the second half of 2017, that
preclinical testing of the Company’s compounds and preliminary data
from clinical trials may not be predictive of the results or
success of ongoing or later clinical trials, that data may not be
available when we expect it to be, that the Company or its
collaboration partner, Celgene, will be unable to successfully
complete the clinical development of its compounds, that the
development of the Company’s compounds will take longer or cost
more than planned, that the Company may be delayed in initiating or
completing any clinical trials, and that the Company’s compounds
will not receive regulatory approval or become commercially
successful products. Other risks and uncertainties include those
identified under the heading “Risk Factors” included in the
Company’s Annual Report on Form 10-K which was filed with the
Securities and Exchange Commission (SEC) on March 17, 2014, and
other filings that the Company may make with the SEC in the future.
The forward-looking statements contained in this press release
reflect the Company’s current views with respect to future events,
and the Company does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
Acceleron Pharma Inc.Kevin F. McLaughlin, 617-649-9204Senior
Vice President and Chief Financial OfficerorMedia:Maureen L. Suda,
585-387-9248Suda Communications LLC
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