Guildford, UK, 15 September 2011: ReNeuron provides a trading update ahead of its Annual General Meeting
We remain greatly encouraged by progress with the PISCES Phase I clinical trial of our ReN001 stem cell therapy for disabled stroke patients. On 13 September, we announced that the first patient in the next dose cohort of three patients had been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This followed a positive recommendation from the independent Data Safety Monitoring Board (DSMB) that the trial can advance to treating this higher dose cohort, based on a review of the safety data from the first dose cohort of three patients treated with ReN001.
The first patient in the PISCES clinical trial was treated almost a year ago. Thus far, the treatment has been well-tolerated by all of the patients treated, with no cell-related adverse events reported. Ongoing patient recruitment continues to progress to plan, with the remainder of the current dose cohort expected to be treated by the end of this year and the remaining two dose cohorts over the course of 2012. In the meantime, we intend to continue our interactions with the regulatory authorities, both with regard to further optimising the PISCES clinical protocol and discussing the design of a subsequent Phase II study with ReN001 to establish the efficacy of the treatment in a larger cohort of stroke patients when measured against an appropriate control group.
As we have previously reported, we also intend to explore the potential of the ReN001 treatment in stroke survivors who are much earlier on in the process of recovering from their stroke, where we believe ReN001 may also provide benefit during the recovery phase.
Our other therapeutic programmes continue to progress to plan. We are taking our ReN009 stem cell therapy for peripheral arterial disease through its remaining late pre-clinical development plan. Our ReN003 collaborative programme for diseases of the retina continues to make progress in partnership with the Schepens Eye Research Institute in Boston, US, the initial clinical target being the blindness-causing disease, retinitis pigmentosa. Subject to available funding, we also plan to explore the potential of our lead CTX neural stem cell line in other neurological conditions where we believe the properties of this cell line may confer benefit.
Subject to emerging data from all of the above activities, as well as ongoing regulatory interactions, we expect, as previously reported, to be in a position to file a number of clinical trial applications in the latter part of 2012. Our current cash resources are sufficient to take us to this point but, as also previously reported, we will prioritise our cell therapy development programmes beyond stroke as necessary over the coming year to ensure that our financial resources remain focused on an emerging clinical pipeline of stem cell therapies offering the greatest potential for clinical benefit, commercial development and value generation for the business.
In July, we announced the appointment of John Berriman and Simon Cartmell as non-executive directors of the Company. We further announced that Bryan Morton, an existing non-executive director, was to become Chairman, which took effect from 1st August 2011. At that point, Professor Trevor Jones stepped down as Chairman in order to establish and chair the Company’s Scientific and Strategic Advisory Group. The remit of this advisory group will be to advise and assist the Company on strategic matters relating to its scientific and commercial agenda, including links to academic and industrial organisations and relationships with government bodies, the media and the public. We are in the process of formally appointing the members of this advisory group and we look forward to making a further announcement shortly in this regard.
Michael Hunt, Chief Executive Officer – ReNeuron +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer – ReNeuron
Lisa Baderoon, Mark Court, Isabel Podda +44 (0) 20 7466 5000
Antony Legge, Oliver Rigby +44 (0) 20 7776 6550
Daniel Stewart & Company plc
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® 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.