- A statistically-significant difference on the primary endpoint
was not reached; however, a positive trend was seen across all
treatment groups, and the primary endpoint was met (p=0.015) for a
subset representing 60% of the population of the CHART-1 study
(baseline End Diastolic Volume (EDV) segmentation).
- Based on the positive subgroup analysis, Celyad will contact
the European Medicines Agency concerning a marketing authorization
application.
- Prof. Jozef Bartunek will present the full 39 weeks' data at
the "Hot Line Heart Failure and Innovative Approaches" Late
Breaking Clinical Trial Session at ESC on Sunday, August 28,
2016.
- Celyad will seek a partner to accelerate further development
and commercialization of C-Cure®.
MONT-SAINT-GUIBERT, Belgium, June 28, 2016 (GLOBE NEWSWIRE)
-- Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a
leader in the discovery and development of engineered cell
therapies, with clinical programs in cardiovascular diseases and
immuno-oncology, today announced headline results for CHART-1, its
European Phase III clinical trial for its lead cardiovascular
disease product candidate.
Across the complete trial population, a positive trend was
clearly identifiable. However, a statistically-significant
difference between treatment and control (sham procedure) was not
reached.
For patients representing 60% of the overall study population
and categorized by their End Diastolic Volume (EDV) at inclusion,
significance was met for the primary endpoint (p = 0.015). Most
importantly, in this subgroup, a strong trend or a statistical
significant positive difference was seen in all individual elements
of the composite primary endpoint (Mortality, Worsening Heart
Failure Events, Quality of Life, 6 minutes Walking Test, End
Systolic Volume and Ejection Fraction).
The study procedure was well tolerated with no safety
concerns.
The CHART-1 trial has been selected by the European Society of
Cardiology to be presented at the "Hot Line Heart Failure and
Innovative Approaches" Late Breaking Clinical Trial session of the
ESC congress in Rome on Sunday, August 28, 2016, at 11:54 am CEST.
The European Society of Cardiology has organized a press conference
scheduled at 8 am CEST on the same day.
Based on the positive results seen in this highly clinically
relevant group of patients for whom treatment options are currently
limited, Celyad will contact the European Medicine Agency
concerning a marketing authorization application.
The Company will use the CHART-1 results as a foundation to
optimize the design of the pivotal CHART-2 US trial. In line with
this, Celyad confirms it is seeking partnerships to accelerate
further development and commercialization of C-Cure®.
At the Company's request, trading in Celyad stock (CYAD.BR) will
be suspended on June 28, 2016, until the completion of the
conference call scheduled at 2:00pm CEST (see details below).
Dr. Christian Homsy, CEO of Celyad, commented: "For the
first time in a randomized, double-blind, controlled, Phase III
cell therapy study, a positive effect, consistent across all
parameters tested, was observed for a substantial, clearly
definable, group of heart failure patients.
CHART-1 has allowed us to better define the patient population
that would benefit from C-Cure®. We are excited by the prospects
for C-Cure® as a new potential treatment option for a highly
relevant heart failure population. We are confident that the
results will generate interest from potential partners that could
accelerate the development and commercialization of C-Cure®."
Prof. Jozef Bartunek, CHART-1 principal co-investigator,
said: "This pioneering study has contributed greatly to our
understanding of heart failure disease and the place of
regenerative medicine in its management. The results seen for a
large clinically relevant number of the patients are ground
breaking. We look forward to completing the full analysis and
making the data available to the medical community at ESC.
On behalf of the CHART 1 steering committee we wish to thank the
patients and families who were enrolled in the study as well as all
the physicians and medical teams that made this study
possible."
Prof. Gerasimos Filippatos, Immediate Past-President of the
Heart Failure Association of the European Society of Cardiology,
member of the CHART-1 dissemination committee, said, "The
CHART-1 results have identified a well-defined group of patients
with symptomatic heart failure despite optimal therapy. Those
patients are a large subset of the heart failure population and
present specific therapeutic challenges. The outcome of
CHART-1 indicate those patients could benefit from this
therapy".
Conference Call Details
A conference all will be held on Tuesday, June 28, 2016 at
2:00pm (CEST) / 8:00am (EDT) to review the topline results of the
CHART 1 study. Christian Homsy, Chief Executive Officer, will
deliver a brief presentation followed by a Q+A session.
Participants are asked to call the assigned numbers
approximately five minutes before the conference call begins.
The call can be accessed by dialing the numbers
below and using the conference ID: 41106485
International:
+44 (0) 1452 560304 Belgium:
024017052 France:
0800918149 UK:
08000738965 US:
18669265708
For more information, please contact:
For Europe: Consilium Strategic Communications Amber
Fennell, Chris Gardner, Chris Welsh, and Laura
Thornton - T: +44 (0)20 3709 5700 -
celyad@consilium-comms.com |
For France : NewCap Pierre Laurent and
Nicolas Mérigeau - T: + 33(0)1 44 71 94 94 -
celyad@newcap.eu |
For Belgium: Comfi Gunther De Backer - T.: +32 (0)2 290
90 90 - gunther@comfi.be |
Celyad Christian Homsy, CEO and Patrick
Jeanmart, CFO : T :
+32 (0)10 39 41 00
investors@celyad.com |
To subscribe to Celyad's newsletter, visit
www.celyad.com Follow us on Twitter @CelyadSA and
LinkedIn
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-1 The 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.
About Celyad Founded in 2007, and based in Belgium,
Celyad is a leader in engineered cell therapy with clinical
programs initially targeting indications in cardiology and
oncology. Celyad is developing its lead cardiovascular disease
product candidate, C-Cure®, for the treatment of ischemic heart
failure, and has completed enrollment of a Phase III trial in
Europe and Israel. In addition, the Company is developing a next
generation portfolio of CAR T-cell therapies that utilize human
Natural Killer cell receptors for the treatment of numerous blood
and solid cancers. Its lead oncology product candidate, NKR-2
(NKG2D CAR T-cell), entered a Phase I clinical trial in April 2015.
Celyad's ordinary shares are listed on Euronext Brussels and
Euronext Paris under the ticker symbol CYAD and Celyad's American
Depositary Shares are listed on the NASDAQ Global Market under the
ticker symbol CYAD. To learn more about Celyad, please visit
www.celyad.com
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
NKR-2-cell therapy and C-Cure® and the clinical potential of the
Company's technology platform generally and the timing of future
clinical trials, 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.
In particular, it should be noted that the safety data described
in the release are preliminary in nature and the Phase 1 trial is
not completed. There is limited data concerning safety and
feasibility of NKR-2. These data may not continue for these
subjects or be repeated or observed in ongoing or future studies
involving our NKR-2 therapy, C-Cure® or other product candidates.
It is possible that safety issues or adverse events may arise in
the future.
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 III
clinical trials for C-Cure® and Phase I clinical trial for 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
prospectus filed with the SEC on June 19, 2015 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. C3BS-CQR-1, C-Cure®, NKG2D
CAR T-cell, NKR-2, OnCyte, Celyad, Celyad, C-CathezTM, CHART-1,
CHART-2 and OnCyte logos are signs internationally protected under
applicable Intellectual Property Laws. Mayo Clinic holds equity in
Celyad as a result of intellectual property licensed to the
Company.
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