We have used our cell expansion and screening technologies to develop “off-the-shelf” stem cell therapies for serious conditions such as stroke where the patient populations are significant and where few if any alternative treatments exist. Unlike conventional drug treatments which typically address the symptoms of disease, the potential of stem cell treatments such as ours is to address the underlying causes of the target disease. Our stem cell treatments have been shown in pre-clinical testing to stimulate natural repair mechanisms in the organs affected by the disease in question, leading to a reduction in the functional impairments associated with the disease.
Our lead therapeutic candidate is our ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. This treatment is currently in clinical development. We are 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.
Our stem cell therapies for stroke and critical limb ischaemia utilise our lead CTX neural stem cell line. The characteristics of this cell line give ReNeuron some distinct technical and competitive advantages in the field. The CTX cell line has been taken through a full manufacturing scale-up and quality-testing process. As such, it represents a standardised, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting with the diseases targeted, without the need for additional immunosuppressive drug treatments. The CTX cells that are being used in the ongoing PISCES Phase I clinical trial with ReN001 in disabled stroke patients have been taken from the existing manufactured cell banks that will form the basis of the eventual marketed product. There will therefore be no need to re-derive and test new cell lines for subsequent ReN001 clinical trials of for the market – all such cells can simply be expanded from the existing banked and tested product.
We have also developed a range of stem cell lines for non-therapeutic applications - our ReNcell® products for use in academic and commercial research. Our ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Merck Millipore.