ReNeuron Group plc AGM Trading Update (9398P)
September 06 2017 - 1:00AM
UK Regulatory
TIDMRENE
RNS Number : 9398P
ReNeuron Group plc
06 September 2017
6 September 2017 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
AGM Trading Update
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the
development of cell-based therapeutics, is pleased to provide a
trading update ahead of today's Annual General Meeting.
We are finalising the relevant data packages to enable us to
submit an IND application to commence a pivotal Phase III clinical
trial with our CTX cell therapy candidate for stroke disability in
the US. We expect to make this submission, as planned, in the final
quarter of this year, with the study expected to commence in early
2018, subject to the requisite regulatory approvals. We expect data
from the Phase III study about two years later, in early 2020.
As previously reported, the FDA specifically recommended that we
apply for a Special Protocol Assessment (SPA) for the proposed
Phase III clinical trial. The SPA process is reserved for clinical
studies considered pivotal in support of product marketing label
claims. Further, 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.
The ongoing US Phase I/II clinical trial of our human Retinal
Progenitor Cell (hRPC) cell therapy candidate for retinitis
pigmentosa (RP) is also proceeding well. We are pleased to report
that all nine patients in the Phase I element of this study have
now been treated, with short term safety and tolerability data
expected in the final quarter of this year. The final high dose
cohort of patients was treated with the newly developed
cryopreserved formulation of our hRPC therapeutic candidate.
In order to garner the appropriate depth and quality of data to
allow subsequent progression to a pivotal study in RP, we are
currently finalising the relevant protocols to enlarge the Phase II
clinical development plan in this indication. Based on this, we
expect additional read-outs from the RP Phase I/II clinical trial
in the second half of 2018, with further Phase II efficacy data
from a larger cohort of patients expected in mid-2019. Further, we
intend to file an application in the final quarter of this year to
commence a Phase II clinical trial with our hRPC cell therapy
candidate in patients with cone-rod dystrophy (CRD), to run
concurrent with the Phase II testing of this candidate in RP. CRD
is a group of rare eye disorders associated with a loss of cone
cells in the retina that initially results in deterioration of
central visual acuity and colour vision. CRD frequently affects
patients in childhood and has no cure. We expect Phase II efficacy
data from the CRD programme in the second half of 2019.
Finally, in conjunction with our academic collaborators, we are
continuing to generate pre-clinical data relating to our exosome
development programme. Exosomes are nanoparticles secreted from
cells including our proprietary CTX stem cell line. They play a key
role in cell-to-cell signalling and early research with ExoPrO, our
first CTX-derived exosome therapeutic candidate, has demonstrated
that it may have a significant effect in regulating cell growth and
apoptosis in cancer.
Over the past year, we have generated and presented important
data relating to the characterisation, purification and in vivo
biodistribution of ExoPrO, demonstrating its potential both as a
novel therapeutic candidate and as a drug delivery vehicle. On the
basis of the above progress and subject to continued success with
ongoing pre-clinical development work, we hope to be able to
commence clinical development with ExoPrO within the next year to
18 months, targeting solid tumours.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"Our therapeutic development programmes continue to progress to
plan, with further near term milestones in prospect as our stroke
programme moves into Phase III clinical development and our retinal
disease programmes move into Phase II clinical development. We look
forward to reporting further progress with these programmes and our
exosome development programme over the coming months."
Olav Hellebø will give a brief presentation at the AGM. The
slides accompanying the presentation will be made available at the
start of the AGM in the Investor section of the Company's website
at www.reneuron.com/investors/presentations
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 Joint Broker)
N+1 Singer Advisory LLP +44 (0) 20 7496 3000
Mark Taylor (Joint 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 drugs that would otherwise lack
adequate capacity to penetrate to their site of action.
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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