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 candidates are our ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke and ReN009 for critical limb ischaemia. Both treatments are in clinical development. We are also developing stem cell therapies for other conditions such as blindness-causing diseases of the retina. ReN001 and ReN009 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. There will be no need to re-derive and test new cell lines for subsequent clinical trials or for the market – all such cells can simply be expanded from the existing banked and tested product.
The ongoing clinical trials of ReN001 and ReN009 utilise a reformulated, cryopreserved variant of the CTX stem cell line, designated CTXcryo. We have generated data demonstrating the equivalence of CTXcryo drug product to the original non-cryopreserved variant. CTXcryo will provide the business with major commercial and competitive advantages in terms of the availability of a genuine off-the-shelf cell-based treatment with a competitive cost of goods and a shelf life enabling shipping to, and storage at, clinical sites on a global basis.
Pre-clinical and clinical results from our technologies and stem cell products have been published extensively in peer-reviewed scientific journals