Celyad (Euronext Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a
leader in the discovery and development of engineered cell
therapies, with clinical programs in cardiovascular disease and
immuno-oncology, today announced that Prof. William Wijns, as
Chairman of the CHART-1 Steering Committee, will oversee the
scientific committee in charge of the data analysis and data
dissemination plan for the trial. In order to avoid any potential
conflict of interest Prof. Wijns will resign from the Board of
Celyad.
Prof. William Wijns has served as a member
of the Board of Directors of the Company since 2007 and is also a
co-founder of the Company. From April 2016, he will step down from
the Board to chair the independent experts’ committee. Prof. Wijns
does not have any remaining interest in the company.
Dr. Christian Homsy, CEO of
Celyad: “William has been at the heart of the C-Cure®
program since 2004. It is of critical importance that the data that
CHART-1 will generate are analyzed with the most stringent
standards and be immune to any possible interpretation of conflict
of interest. Now that our lead clinical program in cardiovascular
disease is close to delivering its results, we thought that
William’s extensive expertise, and his present or past roles at the
European Society of Cardiology, the World Heart Federation, the
European Association of Percutaneous Cardiovascular Interventions
as well as (Euro)PCR would guarantee a rigorous scientific analysis
of the CHART-1 data, as well as a sound and extensive data
dissemination plan.”
Prof. William Wijns: “It is
great to see the fruition of many years of research, from the early
concepts that our team at the Cardiovascular Research Center Aalst
pioneered back in the early 2000, through the development of the
bench research conducted at Mayo Clinic by Prof Andre Terzic and Dr
Atta Behfar, and on to the clinical development lead by Dr Jozef
Bartunek and all the other CHART-1 steering committee
members. We are looking forward to the analysis of this
groundbreaking trial and Celyad’s decision to appoint an
independent scientific committee ensures that this is done to the
highest standards. I am honored and pleased to accept this
function, and the consequence of that decision is the natural move
to step down as Board member of Celyad. I am grateful for the
support of the management and the Board of Celyad that, through the
years, has led the company to its current position of leader in the
cell therapy space. I am excited by my new role, which will
see the culmination of many years of research of this promising
technology.”
About Prof. William Wijns
Prof. Wijns graduated in 1976 from the
University of Louvain in Belgium where he trained as a cardiologist
until 1981. Since 1994, Prof. Wijns has been the co-Director of the
Cardiovascular Center Aalst and active as an interventional
cardiologist. More recently, he has been involved with the clinical
applications of non-invasive coronary angiography with the use of
multislice computed tomography as well as innovative therapies for
cardiovascular diseases, including heart failure. He has authored
500 publications in peer-reviewed journals and holds several
positions in national and international professional and scientific
organizations. He is currently Deputy Editor of the European Heart
Journal (impact factor 14,723). Prof. Wijns previously worked
at the Thorax Center in Rotterdam, where he was actively involved
with the first applications of nuclear cardiology, thrombolysis and
coronary dilatation, and the University of Louvain in Brussels,
where he directed the cardiac PET program and became Clinical
Professor of Cardiology. His research there focused on the
regulation of coronary blood flow and cardiac metabolism in
ischemic heart disease. In the past five years, he has held board
memberships in the European Society of Cardiology and the World
Heart Federation. He is currently Chairman of PCR, co-Director of
Africa PCR and EuroPCR, the official congress of the European
Association of Percutaneous Cardiovascular Interventions.
About CHART-1
CHART-1 (Congestive
Heart failure Cardiopoietic
Regenerative Therapy) is a
patient prospective, controlled multi-centre, randomized,
double-blinded Phase III clinical trial comparing treatment with
C-Cure® to a sham treatment. The trial has recruited 240 patients
with chronic advanced symptomatic heart failure in Europe and
Israel. The primary endpoint of the trial is a composite endpoint
including mortality, morbidity, quality of life, Six Minute Walk
Test and left ventricular structure and function at nine months
post-procedure. The next milestone in the clinical trial will be
the release of the full clinical data set, anticipated for
mid-2016.
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 the U.S. : The Ruth Group Lee
Roth (Investors), and Kirsten Thomas
(Media) - T: +1 646 536 7012 / 7014
- celyad@theruthgroup.com |
For France :
NewCapPierre Laurent and
Nicolas Mérigeau - T: + 33(0)1 44 71 94
94 - celyad@newcap.eu |
For Belgium : ComfiGunther De Backer:
t.: +32 (0)2 290 90 90 – gunther@comfi.be |
CelyadChristian Homsy, CEO and
Patrick Jeanmart, CFO : T :
+32 (0)10 39 41 00
investors@celyad.com |
|
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visit www.celyad.com
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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 novel 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 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 T-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 30-day
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 T-cell therapy. These
data may not continue for these subjects or be repeated or observed
in ongoing or future studies involving our NKR-2 T-cell 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 T-cell; 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®, NKR-2 T-cell, C-Cathez TM,
OnCyte, Celyad, Cardio3 BioSciences and the Cardio3 BioSciences,
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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