Less Ads, More Data, More Tools Register for FREE

Pin to quick picksRENE.L Regulatory News (RENE)

  • There is currently no data for RENE

Further Progress with Stroke Trial

17 Oct 2012 07:00

RNS Number : 8496O
ReNeuron Group plc
17 October 2012
 



 

 

 

17 October 2012

AIM: RENE

 

ReNeuron announces further progress with stroke clinical trial

 

All three patients in penultimate dose cohort successfully treated

 

Guildford, UK, 17 October 2012:  ReNeuron Group plc (the "Company") (AIM: RENE.L) today provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, taking place in Scotland, ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

 

The Company is pleased to report that the third and penultimate dose cohort of three patients have all now been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval given last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this patient cohort.

 

The PISCES study continues to run to plan, with no cell-related serious adverse events reported in any of the patients treated to date. As previously reported, the remaining three, high-dose cohort patients to be treated in the PISCES study have been identified and evaluated as potentially eligible for treatment, with patient enquiries continuing to come into the Glasgow clinical site and a number of patients consequently identified as reserve candidates for the study. Subject to DSMB approval, these final three patients are scheduled to be treated in January and March 2013.

 

In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan. Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

 

Based on the above progress, the Company announced last month that, ahead of plan, it had submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke. This trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which the Company and its clinical collaborators currently believe will be the optimum treatment window for the therapy. Subject to continuing positive progress with the PISCES study, and subject to regulatory and ethical approvals, the Company hopes to be able to commence the Phase II stroke study in mid-2013. The proposed study is expected to take up to 18 months to complete.

 

 

Enquiries:

 

ReNeuron +44 (0) 1483 302560

Michael Hunt, Chief Executive Officer

Dr John Sinden, Chief Scientific Officer

 

Buchanan +44 (0) 20 7466 5000

Mark Court, Fiona Henson, 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 critical limb ischaemia, a serious and common side-effect of diabetes, and blindness-causing diseases of the retina such as retinitis pigmentosa.

 

ReNeuron has also developed a range of stem cell lines for non-therapeutic applications - its ReNcell® products for use in academic and commercial research. The Company's ReNcell®CX and ReNcell®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
 
 
MSCBKADKBBDBKKD
Date   Source Headline
13th Nov 201711:30 amRNSNotification of Interim Results
8th Nov 20177:00 amRNSRetinal disease clinical trial moves into Phase II
31st Oct 20177:00 amRNSPositive stroke clinical data & regulatory update
27th Oct 20177:00 amRNSWins further UK grant
11th Oct 20171:31 pmRNSPDMR Interest in Shares and Share Options
9th Oct 20177:00 amRNSPresentation of positive pre-clinical data
12th Sep 20177:00 amRNSDirectors' Interest in Shares and Share Options
6th Sep 201711:15 amRNSResult of AGM
6th Sep 20177:00 amRNSAGM Trading Update
1st Sep 20177:00 amRNSNon-executive Director Appointment
1st Sep 20177:00 amRNSBlock Listing Review and TVR
7th Aug 20173:04 pmRNSPosting of Annual Report and Notice of AGM
4th Aug 20174:40 pmRNSSecond Price Monitoring Extn
4th Aug 20174:35 pmRNSPrice Monitoring Extension
25th Jul 20177:00 amRNSAppointment of joint broker
19th Jul 20177:00 amRNSBoard change
29th Jun 20177:00 amRNSPreliminary Results
19th Jun 20177:00 amRNSFDA approves cryopreserved hRPC formulation
8th Jun 20177:00 amRNSNotification of Preliminary Results
5th Jun 20177:00 amRNSPositive FDA feedback on proposed Phase III study
18th May 20177:00 amRNSPresents positive exosome data at major conference
11th May 20177:00 amRNSAwarded major UK cell therapy manufacturing grant
5th May 20177:00 amRNSPresents new exosome data at major conference
21st Apr 20177:01 amRNSUpdate on clinical strategy in stroke disability
21st Apr 20177:00 amRNSUpdate on progress in ophthalmology programmes
1st Mar 20177:00 amRNSBlock Listing Review and Total Voting Rights
15th Feb 20177:00 amRNSReNeuron featured in BBC documentary
7th Feb 201712:32 pmRNSDirector Share Purchase
14th Dec 201612:15 pmRNSDirector Share Purchase
5th Dec 20167:00 amRNSInterim Results
5th Dec 20167:00 amRNSReports Positive Results in Phase II Stroke Trial
14th Nov 20167:00 amRNSNotification of Interim Results
5th Oct 20162:30 pmRNSNotification of Major Interest in Shares
22nd Sep 20161:00 pmRNSBlock Listing Review and Total Voting Rights
6th Sep 201612:00 pmRNSResult of AGM
6th Sep 20167:00 amRNSAGM Trading Update
5th Aug 20164:35 pmRNSPosting of Annual Report and Notice of AGM
4th Aug 20167:00 amRNSStroke clinical data published in The Lancet
22nd Jul 20167:00 amRNSPublication of positive pre-clinical retinal data
20th Jul 20162:31 pmRNSDirectors' Interest in Shares and Share Options
7th Jul 20167:00 amRNSPreliminary Results
14th Jun 20167:00 amRNSNotification of Preliminary Results
13th Jun 20167:00 amRNSPatient recruitment completed in stroke trial
9th Jun 20167:01 amRNSPursues brain cancer with exosome platform
8th Jun 20167:00 amRNSRetinitis pigmentosa update & Notice of KOL event
31st May 201612:45 pmRNSChange of Adviser
15th Mar 20167:00 amRNSFirst Patient Treated in RP Clinical Trial
23rd Feb 20167:00 amRNSReNeuron Relocates to South Wales
17th Feb 20164:57 pmRNSDirector's Dealings
3rd Feb 201610:07 amRNSDirector Share Purchase

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.