FDA grants Fast Track Designation for Celyad’s ischemic heart failure therapy, C-Cure®
May 11 2017 - 1:00AM
Celyad (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a leader in the
discovery and development of engineered cell-based therapies, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for its C-Cure® therapy.
FDA granted Fast Track designation for reduction
in mortality, hospitalization and improvement of quality of life in
patients with chronic heart failure secondary to ischemic
cardiomyopathy with baseline Left Ventricular End-Diastolic Volumes
(LVEDV) between 200 and 370ml as Fast Track Development Program.
Celyad’s C-Cure® therapy is one of the most
advanced cell therapies in the heart failure segment. The CHART-1
trial has identified a sizeable patient population with a positive
response to C-Cure®, and a better defined optimal dosing.
This was further validated by the 12 months data
recently presented by Prof. John Teerlink at the late breaking
session of the European Heart Failure Society meeting (Paris, May
1st, 2017), and accepted for publication in the European Journal of
Heart Failure.
In December 2015 Celyad received clearance from
the FDA for CHART-2, a prospective multi-centre, randomized,
sham-controlled, Phase III pivotal study for C-Cure®. The company
is in the process of identifying strategic partners to initiate the
CHART-2 clinical trial.
Dr. Christian Homsy, CEO of
Celyad: “While Celyad focuses its resources on the
development of our immuno-oncology platform, receiving Fast Track
Designation is an important milestone for C-Cure® and is a
testimony to the quality of the science and the strength of the 9
and 12 months CHART-1 data. We hope, with the support
of Piper Jaffray, to be able to identify a partner to carry the
C-Cure program forward.”
The FDA's Fast Track Drug Development Program is
designed to expedite clinical development and submission of New
Drug Applications (NDA) for medicines with the potential to treat
serious or life-threatening conditions and address unmet medical
needs. Specifically, Fast Track designation facilitates frequent
interactions with the FDA review team, including meetings to
discuss all aspects of development to support approval, and also
provides the opportunity to submit sections of an NDA on a rolling
basis as data become available. For more information on Fast Track,
visit the FDA website (http://www.fda.gov).
About CelyadCelyad is a
clinical-stage biopharmaceutical company focused on the development
of specialized cellbased therapies. The Company utilizes its
expertise in cell engineering to target cancer. Celyad’s Natural
Killer Receptor based T-Cell (NKR-T) platform has the potential to
treat a broad range of solid and hematologic tumors. Its lead
oncology candidate, the CAR-T NKR-2, has been evaluated in a single
dose - escalation Phase I clinical trial to assess the safety and
feasibility of CAR-T NKR-2 cells in patients suffering from AML or
MM. This Phase I study was successfully completed in September
2016. Celyad was founded in 2007 and is based in Mont-Saint
Guibert, Belgium, and Boston, Massachusetts. Celyad’s ordinary
shares are listed on the Euronext Brussels and Euronext Paris
exchanges, and its American Depository Shares are listed on NASDAQ
Global Market, all under the ticker symbol CYAD.
About C-Cure®C-Cure® is
Celyad's product candidate based on its cardiopoiesis platform
being evaluated for heart failure. The research underlying this
technology was originally conducted at Mayo Clinic by the research
team of Professor André Terzic and Doctor Atta Behfar, and has been
published in numerous peer-reviewed publications. C-Cure®
consists of a patient's own cells harvested from bone marrow,
treated with a combination of cytokines and growth factors and then
re-injected into the heart. It is designed to enhance reparative
capabilities in the failing heart.
About CHART-1The CHART-1
(Congestive Heart failure
Cardiopoietic Regenerative
Therapy) trial is a Phase III clinical trial to
evaluate C-Cure for the treatment of heart failure. CHART-1 is a
prospective, controlled multi-center, randomized, double-blinded
Phase III clinical trial comparing treatment with C-Cure® to a sham
treatment. The trial recruited 271 evaluable patients with chronic
advanced symptomatic heart failure in 12 countries in Europe and
Israel. The trial is designed to assess the safety and efficacy of
C-Cure®. The primary endpoint of the trial was a composite endpoint
including mortality, morbidity, quality of life, Six Minute Walk
Test and left ventricular structure and function at nine-month
post-procedure.
For more information, please
contact:
For Europe: Consilium Strategic Communications
Chris Gardner and Chris Welsh
- T: +44 (0)20 3709 5700 –
celyad@consilium-comms.com |
For France: NewCapPierre
Laurent and Nicolas Mérigeau - T: +
33(0)1 44 71 94 94 - celyad@newcap.eu |
For Belgium: ComfiGunther De
Backer and Sabine Leclercq - T.: +32 (0)2
290 90 90 – celyad@comfi.be |
For the U.S.: Stern Investor RelationsWill
O’Connor and Michael Schaffzin – T.: +1
212.362.1200 – celyad@sternir.com |
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Forward looking statements
In addition to historical facts or statements of
current condition, this press release contains forward looking
statements, including statements about the potential safety and
feasibility of CAR-T NKR-2 cell therapy, which reflect our current
expectations and projections about future events, and involve
certain known and unknown risks, uncertainties and assumptions that
could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These
forward looking statements are further qualified by important
factors, which could cause actual results to differ materially from
those in the forward-looking statements, including risks associated
with conducting clinical trials; the risk that safety, bioactivity,
feasibility and/or efficacy demonstrated in earlier clinical or
pre-clinical studies may not be replicated in subsequent studies;
risk associated with the timely submission and approval of
anticipated regulatory filings; the successful initiation and
completion of clinical trials, including Phase I clinical trial for
CAR-T NKR-2; risks associated with the satisfaction of regulatory
and other requirements; risks associated with the actions of
regulatory bodies and other governmental authorities; risks
associated with obtaining, maintaining and protecting intellectual
property, our ability to enforce our patents against infringers and
defend our patent portfolio against challenges from third parties;
risks associated with competition from others developing products
for similar uses; risks associated with our ability to manage
operating expenses; and risks associated with our ability to obtain
additional funding to support our business activities and establish
and maintain strategic business alliances and business initiatives.
A further list and description of these risks, uncertainties and
other risks can be found in the Company’s Securities and Exchange
Commission filings and reports, including in the Company’s Annual
Report on Form 20-F filed with the SEC on April 8, 2016 and future
filings and reports by the Company. Given these uncertainties, the
reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. The Company
expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based,
unless required by law or regulation.
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