TIDMRENE
RNS Number : 8408I
ReNeuron Group plc
26 March 2018
26 March 2018 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Product Development Update
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the
development of cell-based therapeutics, is pleased to provide an
update across its research and development programmes.
Highlights
-- CTX stem cell therapy candidate for stroke disability:
- Increase in number of clinical sites planned for Phase IIb study
- First patient treatment expected in mid-2018 leading to top-line data in late 2019
-- hRPC stem cell therapy candidate for retinal diseases:
- Four dose cohorts treated in ongoing Phase I/II study in retinitis pigmentosa
- Phase I/II study to be expanded to target patients with less
impaired vision ahead of future Phase IIb study
- Top line Phase I/II data now expected in H1 2019
-- Exosome nanomedicine platform:
- Initial clinical trial application planned for 2019 in cancer
-- Increasing collaborative work to exploit platforms beyond core therapeutic programmes
CTX stem cell therapy candidate for stroke disability
We have continued our preparations to commence a Phase IIb
clinical study in the US with our CTX cell therapy candidate for
stroke disability. The study, designated PISCES III, is a
randomised, placebo-controlled clinical trial in 110 patients. The
primary end-point of the study will be a comparison of the
proportion of patients in the treated and placebo arms showing a
clinically important improvement on the modified Rankin Scale (mRS)
at 6 months post-treatment compared with baseline. The mRS is a
clinician-reported global measure of disability or dependence upon
others in carrying out activities of daily living and is recognised
by regulatory authorities as an acceptable end-point in late-stage
clinical trials in stroke disability. As previously reported, we
expect the PISCES III study to be one of two pivotal studies
required to support a marketing authorisation for the therapy in
this indication.
We recently announced, on 26 January 2018, the presentation of
positive long term data from the Phase II clinical trial (PISCES
II) of our CTX cell therapy candidate for stroke disability at the
American Heart Association International Stroke Conference 2018.
The data presented at the conference indicate that our CTX therapy
has the potential to produce meaningful and sustained improvements
in the level of disability or dependence as well as motor function
in disabled stroke patients.
We have taken the decision to increase the number of clinical
sites in the PISCES III study from 25 to 40 in order to ensure that
patient recruitment targets in the study are met. On this basis,
and assuming the initial sites in the study are open for
recruitment in the second quarter of this year following local
ethics approvals, we expect first patient dosing in mid-2018 and
top-line data from the study, as previously indicated, in late
2019.
hRPC stem cell therapy candidate for retinal diseases
Four cohorts of three patients each have been dosed in the
ongoing US Phase I/II clinical trial of our hRPC cell therapy
candidate for the blindness-causing inherited retinal disease,
retinitis pigmentosa (RP). This study, which is being undertaken at
Massachusetts Eye and Ear Infirmary in Boston, is an open-label,
dose escalation study to evaluate the safety, tolerability and
preliminary efficacy of our hRPC stem cell therapy candidate in
patients with advanced RP.
We now expect the hRPC therapy to be most effective in RP
patients with a sufficiently intact retina to enable good
engraftment of the hRPC cells and subsequent generation of
functional photoreceptors. We are therefore extending the study in
order to expand the safety database in patients with less impaired
vision than those treated thus far. This is the patient group we
will be targeting in a subsequent clinical trial in RP, which, as
previously reported, will be a controlled Phase IIb study. The
expanded Phase I/II study will also allow us to optimise the
formulation and dosing of the hRPC therapy prior to commencement of
the subsequent study.
Based on the above, we expect short term read-outs from the
ongoing Phase I/II clinical trial later than originally planned, in
the first half of 2019, with the Phase IIb study commencing shortly
thereafter.
As previously announced, we intend to seek approval to commence
a Phase II clinical trial with our hRPC cell therapy candidate in
patients with cone-rod dystrophy (CRD) to begin shortly after the
start of Phase IIb testing of this candidate in RP. CRD is a group
of rare eye disorders associated with a loss of cone cells in the
retina resulting in deterioration of central visual acuity and
colour vision.
Exosome nanomedicine platform
Pre-clinical development work continues with ExoPr0, our first
CTX-derived exosome therapeutic candidate. 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 ExoPr0 has demonstrated its potential as both a
novel therapeutic candidate and as a drug delivery vehicle. Subject
to continued success with ongoing pre-clinical development work, we
hope to be able to commence clinical development with ExoPr0 during
2019, as previously indicated, targeting a solid tumour cancer
indication.
Other activities
We are increasing the scope of our collaborative work with
academic and commercial partners with the aim of exploiting the
potential of our technology platforms beyond our core in-house
therapeutic programmes.
In some cases, this collaborative work is being performed with
the benefit of grant funding. An example of this was our recent
announcement, on 13 February 2018, of the publication of new
positive data with our CTX cell therapy candidate in a pre-clinical
model of nerve injury, which demonstrated comparable nerve
regeneration compared to standard of care treatment and a stronger
muscle function response. The model, using our CTX cells as a
component of artificial nerve tissue, was developed as part of a
grant-funded collaboration with University College London and
Sartorius Stedim Biotech.
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 Wills, 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 disability as a result of stroke 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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