October 5, 2004.
ReNeuron, the UK-based stem cell research and development company, is pleased to give an update on recent progress and future plans regarding its stem cell programmes. The Company is today separately announcing groundbreaking pre-clinical efficacy data with its ReN001 cell therapy programme for stroke. Based on this progress, the Company also announces its intention to seek further funding in order to progress its lead stem cell therapy programmes to the clinic.
ReNeuron's focus is on translating the enormous potential of stem cells into real and practical therapies capable of serving significant unmet or poorly met medical needs. Based around its proprietary c-mycER(TAM) cell immortalisation technology, ReNeuron has now developed a fully controllable system for generating somatic, or lineage-restricted, human stem cell lines. These cell lines have stable, normal genomes and are non-tumour-forming, both pre-requisites for future clinical development. They are also capable of immediate scale-up for clinical use and therefore form the basis of a commercially viable stem cell therapy product.
Over the last year, ReNeuron has developed a rigorous screening and selection process to identify its most promising neural (brain) stem cell lines and has taken these cell lines forward into pre-clinical efficacy testing in various central nervous system disease models. From these studies, the Company has achieved important and unique positive efficacy results in a stroke model using ReN001, one of its lead stem cell lines. These results are being presented today at the American Neurological Association Annual Meeting in Toronto, Canada.
ReNeuron is now taking its ReN001 stem cell therapy for stroke forward into manufacturing scale-up and late pre-clinical testing, and hopes to have approval to commence clinical trials by the end of 2005. The Company believes that ReN001 could be the first such clinical-stage neural stem cell programme addressing a major disease condition.
Other therapeutic programmes
ReNeuron has broadened its stem cell therapy pipeline by initiating programmes addressing a number of other significant and currently incurable diseases.
The Company is deriving pancreatic and retinal stem cell lines and has established academic and commercial partnerships to use these cell lines to develop stem cell therapy treatments addressing Type 1 diabetes (ReN002) and diseases of the retina such as age-related macular degeneration and retinitis pigmentosa (ReN003). Together with ReN001 for stroke, these are ReNeuron's lead stem cell therapy programmes, with pre-clinical efficacy testing scheduled to commence shortly with ReN002 and ReN003.
ReNeuron has also established and presented a method for generating dopamine-producing stem cells at concentrations not achieved elsewhere to the Company's knowledge. This has made possible the initiation of a stem cell therapy programme, ReN004, addressing Parkinson's disease.
Finally, the Company has a programme, ReN005, addressing Huntington's disease. Progress with this programme is in part dependent upon late pre- clinical success with the ReN001 stroke programme, as the same cell line would be used in both indications.
ReNeuron continues to strengthen its patent position in stem cell therapy, having filed a number of new patent applications in the last year.
Non-therapeutic programmes - ReNcell
ReNeuron has generated and presented data showing that its lead ReNcell lines exhibit the electrophysiological and other properties necessary for their use in non-therapeutic applications such as drug discovery. These cell lines are currently under evaluation by a number of commercial and academic organisations. A second generation ReNcell hepatocyte (liver) cell line is under development for toxicology screening applications.
In order to build on its recent successes and progress the above programmes, ReNeuron is seeking between 10 million and 15 million pounds sterling in further private equity funding. The Company will deploy these funds over the next two to three years, taking its ReN001 programme through initial Phase I/II clinical trials, as well as taking its diabetes and retinal programmes through pre-clinical development.
Michael Hunt, Chief Operating Officer and Finance Director of ReNeuron commented:
on has come a long way in the last year, culminating in the breakthrough efficacy data in stroke that we are announcing today. The Company is now poised to take a leading competitive position in the stem cell therapy field. "The funding we are seeking will take ReNeuron into the next phase of its development over the next couple of years or so. By that time, we hope to have achieved the next benchmark position -- first clinical data in our stroke programme and our other lead cell therapy programmes well on their way to the clinic."
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