ReNeuron Group plc (LSE: RENE) today announces that it has appointed Professor Douglas Kondziolka MD, MSc, FRCS, FACS as Principal Investigator for the Phase l clinical study with its ReN001 stem cell therapy for disabled stroke patients. This appointment represents a further step in ReNeuron’s preparations for the clinical phase of its development programme for ReN001.
The Company intends to file an Investigational New Drug (IND) application for ReN001 with the US Food and Drug Administration (FDA) before the end of 2006. Approval of this application will open the way to commencement of a Phase I clinical study in the US, placing ReN001 at the forefront of clinical-stage neural stem cell treatments for major neurological conditions.
Professor Kondziolka is the Peter J. Jannetta Professor and Vice-Chairman of Neurological Surgery, University of Pittsburgh. He is an eminent neurosurgeon and a leading expert in the delivery of cell therapy treatments to stroke patients. He has pioneered a number of neurological procedures in this field as well as developing some of the specialised equipment required to deliver cells to defined locations within the patient’s brain.
Professor Kondziolka works with an experienced clinical team at the University of Pittsburgh Medical Center (UPMC), the site chosen by ReNeuron for the Phase I clinical study with ReN001. This centre also works closely with staff at the nearby Immunologic Monitoring and Cellular Products Laboratory at the Hillman Cancer Center, UPMC, where suspensions of ReNeuron’s ReN001 stem cells will be prepared locally for use in the studies. This is an FDA-approved facility operating to Good Manufacturing Practice (GMP) standards.
As a consequence of his appointment as Principal Investigator, Professor Kondziolka will relinquish his responsibilities as a member of ReNeuron’s Clinical Advisory Board.
Commenting on his appointment, Professor Kondziolka said:
“Stem cell therapy holds tremendous promise for patients with disabling neurological diseases. I am excited by the potential of ReNeuron’s ReN001 treatment for stroke, and I look forward to continued participation in the development of this therapy when it
enters the clinical phase.”
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are delighted that Dr Kondziolka has agreed to lead our ReN001 Phase l clinical study in stroke. His credentials in the field are outstanding and, when approved, the early clinical phase of our ReN001 programme will be in safe hands. This study will represent the first time that stem cells produced using ReNeuron’s proprietary c-mycERTAM expansion technology will have been used to treat a patient. We greatly look forward to that milestone event in the Company’s history.”
Notes to editors
ReNeuron is a leading, UK-based adult stem cell therapy business. The Group 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 means of a chemically-induced safety switch. Cell growth can therefore be completely arrested prior to in vivo implantation.
The Group’s lead stem cell therapy, ReN001 for chronic stroke disability, is in late pre-clinical development. Subject to successful completion of pre-clinical testing, the Company plans to file for approval to commence a Phase I clinical study in stroke by the end of 2006, with the study commencing as soon as possible thereafter.
The Group has also generated pre-clinical efficacy data with its ReN005 stem cell therapy for Huntington’s disease, a rare, genetic and fatal neurodegenerative disorder that affects around 1 in 10,000 people. This programme is in pre-clinical development.
In addition to its stroke and Huntington’s disease programmes, ReNeuron is developing stem cell therapies for Parkinson’s disease, Type 1 diabetes and diseases of the retina.
ReNeuron has also leveraged its stem cell technologies into non-therapeutic areas � its ReNcellTM range of cell lines for use in drug discovery applications in the pharmaceutical industry.
ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L, and its warrants are traded under the symbol RENW.L.
Further information on ReNeuron and its products can be found at www.reneuron.com.
Michael Hunt, CEO
John Sinden, CSO
Tel: 44 (0)1483 302 560
Tel: 44 (0)20 7831 3113