Independent Data Monitoring Committee Initiates process for Interim Analysis of Mesoblast’s Phase 3 Chronic Heart Failure ...
March 31 2017 - 6:00AM
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that
the Independent Data Monitoring Committee (IDMC) for the ongoing
Phase 3 trial in chronic heart failure (CHF) has initiated the
process for the pre-specified interim futility analysis of the
trial’s efficacy endpoint.
The interim analysis dataset has been locked and will be
analyzed and reviewed by the trial’s independent statisticians.
Throughout this review process, Mesoblast will remain blinded to
individual treatment allocation as well as grouped safety and
efficacy data.
The dataset for the interim analysis includes non-fatal and
terminal cardiac events from the first 270 of the anticipated 600
patients to be included in this ongoing trial. The IDMC will
review and interpret the results of the interim analysis and
provide recommendations shortly.
The trial’s efficacy endpoint is a comparison of recurrent heart
failure-related major adverse cardiac events (HF-MACE) in moderate
to advanced CHF patients receiving either MPC-150-IM by catheter
injection into the damaged left ventricular heart muscle or sham
control. Enrollment in the 1:1 randomized Phase 3 trial is ongoing
across multiple study sites in the United States and Canada.
About MPC-150-IM and the Unmet Need of Chronic Heart
FailureMPC-150-IM is Mesoblast's lead allogeneic,
cell-based product candidate for the treatment of moderate to
advanced chronic heart failure (CHF) due to left ventricular
systolic dysfunction. In 2016, more than 15 million patients
in the seven major global pharmaceutical markets are estimated to
have been diagnosed with CHF.1 Prevalence is expected to grow
46% by 2030 in the United States alone, affecting more than 8
million Americans.2
CHF is a progressive disease and is classified in
relation to the severity of the symptoms experienced by the
patient. The most commonly used classification system was
established by the New York Heart Association (NYHA) and ranges
from Class I (mild) to Class IV or end stage (severe).
Approximately half of people who develop heart failure die within 5
years of diagnosis.3 Patients with late NYHA Class II or Class
III CHF continue to represent a significant unmet medical need
despite recent advances in new therapies. CHF causes severe
economic, social, and personal costs. In the United States, it is
estimated that CHF results in direct costs of $60.2 billion
annually when identified as a primary diagnosis and $115 billion as
part of a disease milieu.4
About Mesoblast’s Phase 3 CHF TrialMesoblast’s
Phase 3 trial in CHF is a multicenter, double-blind, randomized,
scripted sham procedure-controlled, parallel-group study to
evaluate the efficacy and safety of MPC-150-IM cell therapy (human
bone marrow-derived adult allogeneic mesenchymal precursor cells)
in patients with moderate to advanced CHF due to left ventricular
systolic dysfunction of either ischemic or non-ischemic etiology
who have received optimal medical and coronary revascularization
therapy. 1GlobalData-PharmaPoint (2016):Heart Failure-Global
Drug Forecast and Market Analysis to 20252AHA Statistical Update -
Heart Disease and Stroke Statistics-(2017). Circulation.
2017;131:00-00. DOI:
10.1161/CIR.00000000000004853 1.Mozzafarian D, Benjamin EJ, Go
AS, et al. on behalf of the American Heart Association Statistics
Committee and Stroke Statistics Subcommittee. Heart disease and
stroke statistics -- 2016 update: a report from the American Heart
Association. Circulation. 2016;133:e38-e3604 A Re-Evaluation
of the Costs of Heart Failure and its Implications for Allocation
of Health Resources in the United States. Voigt J. Clinl.Cardiol.
37, 5, 312-321 (2014)
About MesoblastMesoblast Limited (Nasdaq:MESO)
(ASX:MSB) is a global leader in developing innovative cell-based
medicines. The Company has leveraged its proprietary technology
platform, which is based on specialized cells known as mesenchymal
lineage adult stem cells, to establish a broad portfolio of
late-stage product candidates. Mesoblast’s allogeneic,
‘off-the-shelf’ cell product candidates target advanced stages of
diseases with high, unmet medical needs including cardiovascular
diseases, immune-mediated and inflammatory disorders, orthopedic
disorders, and oncologic/hematologic conditions.
Forward-Looking StatementsThis press release
includes forward-looking statements that relate to future events or
our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. We make such forward-looking statements pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Forward-looking
statements should not be read as a guarantee of future performance
or results, and actual results may differ from the results
anticipated in these forward-looking statements, and the
differences may be material and adverse. You should read this press
release together with our risk factors, in our most recently filed
reports with the SEC or on our website. Uncertainties and risks
that may cause Mesoblast's actual results, performance or
achievements to be materially different from those which may be
expressed or implied by such statements, and accordingly, you
should not place undue reliance on these forward-looking
statements. We do not undertake any obligations to publicly update
or revise any forward-looking statements, whether as a result of
new information, future developments or otherwise.
For further information, please contact:
CORPORATE COMMUNICATIONS
Julie Meldrum
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com
INVESTOR RELATIONS
Schond Greenway
T: +1 212 880 2060
E: schond.greenway@mesoblast.com
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