LONDON, May 8, 2019 /PRNewswire/ -- ReNeuron
Group plc (AIM: RENE), a global leader in the development of
cell-based therapeutics, announced a year-end business update ahead
of its preliminary results for the year ended March 31, 2019, which will be announced on
Thursday, July 11, 2019.
"We are greatly encouraged by the progress we have made with our
cell therapy clinical development programs for retinitis pigmentosa
(RP) and stroke disability since our interim financial results
update last December. Both the hRPC and CTX studies are
expected to continue to yield meaningful clinical data during the
course of 2019 and 2020. We are pleased to be working
with Fosun Pharma as our partner for China and are encouraged by the level of
interest other potential collaborators are showing in all of our
programs. We look forward to continuing to advance our
clinical and business development activities in the months ahead,"
said Olav Hellebø, Chief Executive Officer of
ReNeuron.
Recent Highlights from Clinical Programs
- hRPC for Retinal Disease
ReNeuron has made
significant progress advancing the clinical development of the
Company's human retinal progenitor cell (hRPC) therapy candidate in
the blindness-causing disease, retinitis pigmentosa (RP). Most
recently, on April 26, 2019, the
Company reported positive preliminary data in the first cohort of
the Phase 2a part of its study of hRPC in RP. All three subjects in
the cohort demonstrated a rapid and sustained improvement in vision
compared with their pre-treatment baseline.
Dosing of the second cohort in the study is now complete. The
second cohort comprised three patients with a greater baseline
level of visual acuity than those patients earlier in the
study. The clinical protocol for the study allows for up to
12 patients (four cohorts of three patients each) to be treated in
the Phase 2a part of the study. The Company expects to treat
the final six patients of the study this summer and to report data
from all 12 of the Phase 2a subjects in the second half of this
calendar year. These results will form the basis of the
Company's interactions with the European and US regulatory
authorities regarding the remaining clinical development path of
hRPC for the treatment of RP.
ReNeuron's RP clinical programme benefits from Orphan Drug
Designation in both Europe and the
U.S., as well as Fast Track designation from the U.S. Food and Drug
Administration (FDA).
- CTX for stroke disability
ReNeuron is continuing to progress the clinical development of its
CTX cell therapy candidate for stroke disability. In January 2019, the Company announced that patient
dosing had commenced in PISCES III, a randomised,
placebo-controlled, Phase 2b clinical
trial in 110 patients at up to 40 clinical trial sites in the
U.S.
ReNeuron is currently evaluating the optimum global development
plan for the CTX cell therapy candidate for stroke
disability. Subject to relevant regulatory approvals, the
ongoing PISCES III study may be expanded to include clinical sites
in China. On April 9, 2019, the Company announced the signing
of an exclusive licence agreement with Shanghai Fosun
Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma")
for the development, manufacture and commercialisation of
ReNeuron's CTX and hRPC cell therapy programs in the People's
Republic of China. Potential expansion of the PISCES III study
into China would be conducted in
conjunction with Fosun Pharma.
Subject to finalization of the clinical development plan for CTX,
and based on current patient recruitment and resource planning,
ReNeuron expects to report top-line data from the PISCES III study
during the second half of 2020, later than the original guidance of
early 2020. The Company expects the PISCES III clinical
trial, if positive, to be one of two pivotal studies required to
support marketing authorisations for CTX in stroke disability.
- Exosome Technology
ReNeuron is pursuing opportunities
to capitalise on the significant scientific and life sciences
industry interest in exosomes by forming near-term,
value-generating, business partnerships covering the Company's
exosome technology. ExoPr0, the first CTX-derived exosome
candidate arising from this technology, is being developed as a
novel vector for delivering third party biological drugs.
In January 2019, ReNeuron signed a
collaboration agreement with a US-based biopharmaceutical company
to explore the use of the Company's exosome technology to create
delivery vehicles for synthetic oligonucleotides used in gene
therapy. ReNeuron is in active discussions with other
commercial third parties regarding potential collaboration
agreements for the Company's exosome technology.
Business Development Activities
ReNeuron's technologies and therapeutic programs have
increasingly attracted the interest of commercial third parties, as
demonstrated by the Company's recent licence agreement with Fosun
Pharma. The Company is in discussions with other commercial
third parties regarding potential collaboration and/or
out-licensing deals across ReNeuron's programs.
Financial Results
ReNeuron's unaudited financial results for the year ended
March 31, 2019 remain in line with
the Board's previous expectations.
The Company had unaudited cash, cash equivalents and bank
deposits totalling £26.39 million as of March 31, 2019 (March 31,
2018 audited: £37.41 million). The Directors expect
that the Company's current financial resources, combined with the
£6.0 million upfront fee and near-term milestone income from the
above-mentioned licence agreement with Fosun Pharma, will be
sufficient to support operations for at least the next 12 months
from the date of this announcement.
Notification of Preliminary Results
ReNeuron will announce its preliminary results for the year
ended March 31, 2019 on Thursday, July 11, 2019. A meeting for analysts
will be held at 10.00am BST
(5:00 a.m. ET) on the morning of the
announcement, at the offices of Buchanan, 107 Cheapside,
London EC2V 6DN. Further
details regarding the analyst meeting will be announced in due
course.
About ReNeuron
ReNeuron is a global leader in cell-based therapeutics,
harnessing its unique stem cell technologies to develop
'off-the-shelf' stem cell treatments, without the need for
immunosuppressive drugs. The Company's lead clinical-stage
candidates are in 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 delivery system for drugs that would
otherwise be unable to reach 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.
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SOURCE ReNeuron Group plc