Cell therapy programmes

ReN001 is our most advanced stem cell therapy programme, targeting patients who have been left disabled by an ischaemic stroke, the most common form of the condition. Our ReN001 therapy is based around our lead neural stem cell line, designated CTX, by virtue of its origin from the cortex region of the brain.

Patient recruitment for a ground-breaking, first-in-man clinical trial has recently commenced in the UK. This Phase I clinical study is a safety study in a small number of disabled stroke patients.The study will provide a read-out on the safety of the ReN001 therapy but will also provide some early indications of potential efficacy.

For more information on stroke please click here

Our other cell therapy programmes are at the research or pre-clinical stages of development. Our ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. We are also developing stem cell therapies for other conditions such as blindness-causing diseases of the retina. These programmes utilise either the CTX cortical cell line or separate cell lines generated from the region of the brain or body appropriate to the disease in question.

We have developed a full pre-clinical safety package for the CTX cell line, and it has already been scaled up to cGMP manufacturing standards.We therefore intend to leverage the investment made in this cell line by applying it to other conditions where we believe it may have a beneficial effect as a cell-based therapy.The pre-clinical development pathway for the CTX cell line in these additional indications should be faster and less costly, given the data package already generated for the cell line as part of the ReN001 stroke programme.

Our aim is to file further clinical trial applications beyond ReN001 within the next two years. The degree to which each of these programmes is resourced and progressed will depend on the relative strength of pre-clinical data emerging, and the relative speed with which each programme can be progressed to the clinic based on these data. Much of the ongoing development work in these programmes is being undertaken in collaboration with leading international academic institutions, such as the Schepens Eye Research Institute (Harvard Medical School) in respect of our retinal cell therapy programme.

Ultimately, we expect to realise value by out-licensing our stem cell therapies to commercial development partners at the appropriate points in their respective development programmes.

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