ReNeuron Group plc Positive FDA feedback on proposed Phase III study (0891H)
June 05 2017 - 1:00AM
UK Regulatory
TIDMRENE
RNS Number : 0891H
ReNeuron Group plc
05 June 2017
AIM: RENE 5 June
2017
ReNeuron Group plc
ReNeuron progresses clinical and regulatory strategy for the US
with stroke programme based on positive FDA regulatory feedback
ReNeuron to apply for Special Protocol Assessment and
Regenerative Medicine Advanced Therapy designation as part of US
Phase III clinical trial application in stroke disability
ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based
global leader in the development of cell-based therapeutics, is
pleased to provide a further update regarding its US clinical and
regulatory development strategy for its CTX cell therapy candidate
for stroke disability.
We are pleased to report that we received favourable feedback
from the FDA at the End of Phase II meeting conducted in April
regarding our stroke programme. This favourable feedback was
confirmed in the full minutes of the meeting, which we have now
received. The FDA responded positively to our proposals regarding
the design and conduct of the proposed Phase III clinical trial
with CTX in patients with disability post-stroke. Significantly,
the FDA specifically recommended that we apply for a Special
Protocol Assessment (SPA) for the Phase III study. The SPA process
is exclusively reserved for studies considered potentially pivotal
in support of product marketing label claims.
Based on the FDA's recommendation, we plan to apply for an SPA
for our proposed Phase III clinical trial with CTX for stroke
disability.
As part of our US regulatory strategy, we also plan to apply for
Regenerative Medicine Advanced Therapy (RMAT) designation for our
CTX cell therapy candidate for stroke disability. The benefits of
RMAT designation are similar to those of Breakthrough Therapy
designation, including increased interactions with the FDA during
development and eligibility for priority review and accelerated
marketing approval.
We are now working to finalise the relevant data packages to
enable us to submit both the SPA and RMAT designation applications
within the broader IND application to commence a Phase III clinical
trial with CTX for stroke disability in the US. We expect to make
this combined submission in the final quarter of this year, with
the study now expected to commence in early 2018, subject to the
requisite regulatory approvals.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are greatly encouraged by the feedback we have received from
the FDA regarding our planned US pivotal Phase III clinical trial
with our CTX cell therapy candidate for stroke disability, most
especially the recommendation that we seek a Special Protocol
Assessment for the study. We take this feedback as an endorsement
of our proposed approach to this important clinical trial and
further recognition of the very large unmet medical need
represented by patients left with lasting disabilities following an
ischaemic stroke."
ENDS
ENQUIRIES:
ReNeuron +44 (0)20 3819 8400
Olav Hellebø , Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan +44 (0) 20 7466 5000
Mark Court, Sophie Cowles, Stephanie Watson
Stifel Nicolaus Europe Limited +44 (0) 20 7710 7600
Jonathan Senior, Stewart Wallace, Ben Maddison (NOMAD and Broker)
About ReNeuron
ReNeuron is a leading, clinical-stage cell therapy development
company. Based in the UK, its primary objective is the development
of novel cell-based therapies targeting areas of significant unmet
or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop
cell-based therapies for significant disease conditions where the
cells can be readily administered "off-the-shelf" to any eligible
patient without the need for additional immunosuppressive drug
treatments. The Company has therapeutic candidates in clinical
development for motor disability as a result of stroke, for
critical limb ischaemia and for the blindness-causing disease,
retinitis pigmentosa.
ReNeuron is also advancing its proprietary exosome technology
platform as a potential new nanomedicine targeting cancer and as a
potential delivery system for gene therapy treatments.
ReNeuron's shares are traded on the London AIM market under the
symbol RENE.L. Further information on ReNeuron and its products can
be found at www.reneuron.com.
This announcement contains forward-looking statements with
respect to the financial condition, results of operations and
business achievements/performance of ReNeuron and certain of the
plans and objectives of management of ReNeuron with respect
thereto. These statements may generally, but not always, be
identified by the use of words such as "should", "expects",
"estimates", "believes" or similar expressions. This announcement
also contains forward-looking statements attributed to certain
third parties relating to their estimates regarding the growth of
markets and demand for products. By their nature, forward-looking
statements involve risk and uncertainty because they reflect
ReNeuron's current expectations and assumptions as to future events
and circumstances that may not prove accurate. A number of factors
could cause ReNeuron's actual financial condition, results of
operations and business achievements/performance to differ
materially from the estimates made or implied in such
forward-looking statements and, accordingly, reliance should not be
placed on such statements.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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