Cell Manufacturing Contract (4226D)
16 5월 2012 - 3:01PM
UK Regulatory
TIDMRENE TIDMABH
RNS Number : 4226D
ReNeuron Group plc
16 May 2012
16 May 2012 AIM: RENE
ReNeuron Group plc
(the "Company")
ReNeuron Signs Cell Manufacturing Contract for Completion of
Stroke Clinical Trial
Recruitment of patients for remaining two dose cohorts on
track
Guildford, UK, 16 May 2012: ReNeuron Group plc (the "Company")
(LSE: RENE.L) announces that it has signed a new cell manufacturing
contract with Angel Biotechnology Holdings plc (AIM:ABH), a
biopharmaceutical contract manufacturer, to perform GMP drug
product manufacturing services to serve the remaining part of the
PISCES Phase I clinical trial of ReNeuron's ReN001 stem cell
therapy for stroke.
The final patient in the second dose cohort of the PISCES study
was treated last month, as scheduled. The Glasgow clinical site has
also identified potentially eligible patients for all of the
remaining two dose cohorts in the study. Two further UK clinical
sites are in the process of being approved to recruit patients into
the PISCES study should this be necessary to meet recruitment
targets. It is envisaged that these further clinical sites will
also participate as centres in a Phase II clinical trial with
ReN001 in due course.
As recently reported, the Company therefore expects that,
subject to a continuing lack of cell-related adverse events and
affirmative Data Safety Monitoring Board advice, the remaining dose
cohorts in the PISCES study will have been treated within the next
twelve months, leaving the Company on track to submit an
application for a Phase II clinical study with ReN001 during the
course of next year.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
"We are pleased to continue our manufacturing partnership with
Angel to serve the needs of the ongoing PISCES stroke clinical
trial, and we look forward to seeing the higher dose cohorts in the
study treated with our ReN001 stem cell therapy over the coming
months."
Enquiries:
ReNeuron +44 (0) 1483 302560
Michael Hunt, Chief Executive Officer
Pat Huggins, Head of Finance
Buchanan +44 (0) 20 7466 5000
Mark Court, Sophie Cowles
Cenkos Securities +44 (0) 20 7397 8900
Stephen Keys, Adrian Hargrave (NOMAD and Broker)
Andy Roberts (Sales)
About ReNeuron
ReNeuron is a leading, clinical-stage stem cell business. Its
primary objective is the development of novel stem cell 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. ReNeuron's lead candidate is its ReN001 stem cell
therapy for the treatment of patients left disabled by the effects
of a stroke. This therapy is currently in clinical development. The
Company is also developing stem cell therapies for other conditions
such as peripheral arterial disease, a serious and common
side-effect of diabetes, and blindness-causing diseases of the
retina.
ReNeuron has also developed a range of stem cell lines for
non-therapeutic applications - its ReNcell(R) products for use in
academic and commercial research. The Company's ReNcell(R) CX and
ReNcell(R) VM neural cell lines are marketed worldwide under
license by USA-based Merck Millipore.
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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