Plans to initiate phase 2 study of dalantercept plus sorafenib in
hepatocellular cancer in the first half of 2014
Remains on track to initiate pivotal trial with sotatercept or
ACE-536 in late 2014 or early 2015
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical
company focused on the discovery, development and commercialization of
novel protein therapeutics for cancer and rare diseases, today provided
an update on the status of its research and development programs at the
Piper Jaffray 25th Annual Healthcare Conference in New York.
"We are pleased with the progress of our clinical pipeline and remain on
track to achieve the goals we've previously outlined, including
reporting interim data from the sotatercept trial in beta-thalassemia
next week at the American Society of Hematology Annual Meeting," said
John Knopf, Ph.D., Chief Executive Officer of Acceleron. "Notably, our
clinical development of dalantercept is progressing nicely and we're
excited to announce plans to initiate a phase 2 study in patients with
hepatocellular cancer in the early part of 2014. We look forward to
providing additional updates on our pipeline progress over the coming
In the ongoing phase 2 clinical trial of dalantercept plus axitinib in
patients with renal cell carcinoma, Acceleron has completed dose
escalation and is now enrolling patients in the expansion stage of
this study. Acceleron expects to achieve its previously stated goal of
initiating the randomized, placebo-controlled stage of this trial by
the end of the first quarter of 2014.
Based on the activity and tolerability observed in the ongoing renal
cell carcinoma study in which patients are treated with the
combination of dalantercept and axitinib, Acceleron has decided to
initiate a combination study with dalantercept and sorafenib in
patients with hepatocellular cancer (HCC). Acceleron previously stated
plans to initiate its next dalantercept clinical trial by the end of
the third quarter of 2014, but now expects to initiate this
combination trial in HCC in the first quarter or early in the second
quarter of 2014.
The Gynecologic Oncology Group (GOG) is conducting two monotherapy
clinical trials to explore the single agent activity of dalantercept
in ovarian and endometrial cancers. Both of these clinical trials are
designed as two-stage studies. If there is sufficient clinical
activity to potentially warrant development of dalantercept as a
single agent in this first stage of the study, additional patients
will be enrolled in the second stage of the trial. All of the patients
have been enrolled in the first part of the ovarian cancer trial and
the study is ongoing. In the endometrial cancer study, the GOG has
determined that there was not sufficient activity to warrant
development of dalantercept as a monotherapy for endometrial cancer
and will not advance to the second stage of this trial.
Sotatercept and ACE-536
New interim clinical data from the phase 2 trial of sotatercept in
patients with beta-thalassemia will be presented at 2013 American
Society of Hematology Annual Meeting in New Orleans on December 9th.
The presentation will include new interim data from the 0.5 mg/kg dose
group as well as data from the 0.1 and 0.3 mg/kg dose groups in this
Sotatercept and ACE-536 clinical trials in beta-thalassemia and
myelodysplastic syndromes are progressing on schedule.
Celgene and its collaborators continue to explore sotatercept in
additional clinical studies including anemia of chronic kidney
disease, Diamond-Blackfan anemia, myelofibrosis and multiple myeloma.
Additionally, Acceleron and Celgene are exploring the preclinical
activity of sotatercept and ACE-536 in other red blood cell disorders
including Sickle Cell Disease.
Acceleron and Celgene remain on track to initiate a registration
enabling study with either sotatercept or ACE-536 by the end of 2014
or the beginning of 2015.
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, ACE-536, 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
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, 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 Registration
Statement on Form S-1 which was declared effective by the Securities and
Exchange Commission (SEC) on September 18, 2013, 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
Steven Ertel, 617-649-9234
President and Chief Business Officer
Maureen L. Suda, 585-387-9248
Source: Acceleron Pharma
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