Regulatory News:
Celyad (Paris:CYAD) (Brussels:CYAD) (Euronext Brussels and
Paris, and 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.
***END***
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
withC-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.
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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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version on businesswire.com: http://www.businesswire.com/news/home/20160207005009/en/
For Europe :Consilium Strategic
CommunicationsAmber Fennell, Chris Gardner,
Chris Welsh, and Laura Thornton, T: +44 (0)20 3709
5700 –celyad@consilium-comms.comorFor the U.S. :The Ruth
GroupLee Roth (Investors), and Kirsten Thomas
(Media), T: +1 646 536 7012 /
7014celyad@theruthgroup.comorFor
France :NewCapPierre Laurent and Nicolas
Mérigeau, T: + 33(0)1 44 71 94 94celyad@newcap.euorFor
Belgium :ComfiGunther De Backer, t.: +32 (0)2 290 90
90gunther@comfi.beorCelyadChristian Homsy, CEO
and Patrick Jeanmart, CFO, T : +32 (0)10 39 41
00investors@celyad.com
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