Guildford, UK, 22 September 2005: ReNeuron Group plc (LSE: RENE.L) today announced that it has held a formal pre-IND1 meeting with the CBER2 component of the US Food & Drug Administration (FDA) regarding its lead ReN001 stem cell therapy to treat chronic disability after stroke.
The Company attended the meeting in July with reviewers from CBER, the group within the FDA responsible for the evaluation of biologics, including cell and gene therapies. The pre-IND meeting followed informal discussions with members of CBER concerning the ReN001 programme, and the subsequent submission of a pre-IND dossier by the Company.
The Company has now received and reviewed the official minutes of the pre-IND meeting. As a result, ReNeuron is maintaining its pre-clinical development timelines for its ReN001 stroke programme and, subject to successful completion of pre-clinical testing, remains confident of achieving its goal of filing an IND application (to commence initial clinical trials) with the FDA by mid-2006.
Whilst working to meet the FDA’s pre-clinical requirements with respect to the ReN001 programme, ReNeuron is also meeting with the equivalent UK and European regulators in order to determine the regulatory requirements for ReN001 in European markets.
Commenting on the announcement, Michael Hunt, CEO of ReNeuron, said:
“ReNeuron’s ReN001 stem cell therapy for stroke is a pioneering development programme, and therefore one where we believe collaboration between ReNeuron and the regulatory authorities is critical in defining the safety and performance criteria for the therapy. We are grateful to the CBER team for their constructive comments and assistance in helping the Company to define the most appropriate development strategy for ReN001, and we look forward to further positive interaction with CBER and the regulatory authorities in Europe as ReN001 progresses towards the clinic.”
1Investigational New Drug
2Center for Biologics Evaluation and Research
Notes to editors
ReNeuron is a leading, UK-based adult stem cell therapy business. The Company is applying its novel stem cell platform technologies in the development of ground-breaking stem cell therapies to serve significant and unmet or poorly-met clinical needs.
ReNeuron has used its c-mycERTAM technology to generate genetically stable neural stem cell lines. This technology platform has multi-national patent protection and is fully regulated by way of a chemically-induced safety switch. Cell growth can therefore be completely arrested prior to in vivo implantation.
The Company’s lead stem cell therapy, ReN001 for chronic stroke disability, is in late pre-clinical development. The Company plans to file for approval to commence initial clinical trials in stroke by mid-2006, with trials commencing as soon as possible thereafter. If this application is successful, the Company believes that its ReN001 programme would be the world’s first clinical-stage neural stem cell therapy for stroke patients.
In addition to its ReN001 stroke programme, ReNeuron has programmes to develop stem cell therapies to address Huntington’s disease, Parkinson’s disease, Type 1 diabetes and diseases of the retina.
ReNeuron has also leveraged its stem cell technologies into non-therapeutic areas such as drug discovery – its ReNcellTM product.
The Company successfully completed its flotation on the London AIM market in August 2005, raising £9.5million before expenses. At flotation, the Company also issued warrants which, if exercised, will raise a further £5.7m for the Company by February 2007. ReNeuron’s shares are traded under the symbol RENE.L, and its warrants are traded under the symbol RENW.L.
Michael Hunt, CEO
John Sinden, CSO
Tel: 01483 302 560
Tel: 020 7831 3113
The terms “ReNeuron” or “the Company” refer to ReNeuron Group plc and its subsidiary undertakings.