ReNeuron says 12 months on, first stroke patient remains well; no “cell-related adverse events"

ReNeuron Group (LON:RENE) said this morning that the first ever stroke patient to be treated with its stem cell therapy remains well with no “cell-related adverse events reported”.

This is an important milestone for the company and the pilot investigation of stem cells in stroke, also known as the PISCES study.

In all, 12 patients will be given varying doses of ReNeuron’s ReN001 stem cell treatment as part of this early-stage trial being carried out in Scotland at the Institute of Neurological Sciences. 

One group of four, known as a cohort, has already received the lowest dose of ReN001, and the first patient of the second cohort was recently treated.

ReNeuron said this morning that the independent Data Safety Monitoring Board for the clinical trial has reviewed the status this patient after 28 days.

And it has given the go ahead for the ReN001 to be administered to the other three patients in the second dose cohort.

The company said it expects all the remaining patients in the PISCES trial will be treated next year.

ReNeuron chief executive Michael Hunt said: "The 12-month follow-up visit of the first patient treated is an important milestone in the PISCES study and we are delighted that he remains well and that no cell-related adverse events have arisen.  

The company will provide a further update on the PISCES clinical trial in its 2011 interim results statement to be announced on November 28.  

In addition, Professor Keith Muir, the principal investigator for the PISCES study, will give a progress report on the trial to the Stroke Association's 6th Stroke Forum Conference, which takes place in Glasgow from November 29 to December 1.

The development of stem cells in order to treat diseases is significant because of their ability to both renew themselves and create new cells of other kinds of tissues. 

So, while bone marrow transplants are already used to treat leukaemia, other stem cell therapies may one day be used to treat a wide range of diseases, including cancer and multiple sclerosis.

Despite this, stem cells have proved a highly controversial issue, mainly in relation to those garnered from embryos. 

However, ReNeuron derives its stem cell products from non-embryonic human tissue sources.

The ReN001 therapy is based around ReNeuron’s lead neural stem cell line, designated CTX by virtue of its origin from the cortex region of the brain. 

The firm’s other stem cell therapies include ReN009, targeted at peripheral arterial disease (PAD), and ReN003, its therapy programme focused on diseases of the retina.

PAD is a chronic, debilitating disease that progressively restricts blood flow in the limbs, causing cramping and chronic pain, and in rare cases it can lead to the loss of a limb. 

During the past year, ReNeuron’s collaborators on its ReN009 programme at the Bristol Heart Institute have presentedpositive pre-clinical efficacy data.

It is continuing to collaborate with the Schepens Eye Research Institute at Havard Medical School on its ReN003 programme. 

Last December ReNeuron successfully raised £10 million via an oversubscribed share placing which should be sufficient to support current operations into 2012.  

According to Daniel Stewart the current share price of 4.3 pence, down around 30 per cent in the year to date, seriously under-estimates the potential of ReNeuron’s cutting edge technology. 

Setting a 13 pence price target, analyst Vadim Alexandre said recently: “We believe that ReNeuron is materially undervalued given the significant commercial momentum building within the regenerative medicine sector.”