The scoop I want to bring to your attention today is a little tricky...
On the one hand this unique company is doing very noble and potentially groundbreaking research, which could lead to a cure for all manner of life threatening diseases. On the other, the method they're using, although considered vital by some, courts great controversy.
So be warned... the company I want to talk to you about may come up against some ethical issues.
The fact that they are using stem cells from the developing brains of 12 week old aborted foetuses may cause some concern.
ReNeuron (RENE) hope to make this more acceptable to ethical groups by highlighting the fact that one foetus will produce multiple stem cells that could help pave the way for cures from diseases such as stroke, diabetes and Parkinson's.
It hasn’t caused much concern to investors... shares roared ahead following their recent statement.
And I guess here's why....
The potential for this company could be vast...
Strokes are the single largest cause of adult disability in the developed world. In the UK and America alone over 800,000 people suffer a stroke each year. Stroke is the country’s third biggest killer.
It’s sad but true that each and every one of us has probably been affected by, or knows someone that has suffered from a stroke.
And only last week ReNeuron announced the filing of its first Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to commence initial clinical studies in the US with ReN001, its stem cell therapy for stroke.
Remember there’s still a long way to go... not only do they have to make sure this is morally acceptable, there are also safety issues to deal with... More specifically the genetic modification of foetal cells can lead to uncontrolled cell division, which in turn can trigger the production of abnormal or cancerous cells.
And they're only just filing their application with the FDA who are notoriously slow when it comes to making decisions. The clinical trials are also always very lengthy and it has to make it through three very rigorous tests.
Still, this is a major breakthrough in medicine and ReNeuron believe it is the world’s first such application concerning a neural stem cell treatment for a major neurological disorder.
As such the filing is a key milestone in ReNeuron’s history.
ReNeuron's ReN001 stem cell therapy seeks to treat those patients who've suffered a stroke and have been left disabled by it.
These patients constitute approximately one third of the total stroke patient population. Currently there are no approved treatments available to address the causes of their disability. Existing treatments for stroke in the chronic phase are primarily focused on the prevention of recurrent strokes.
The annual health and social costs of caring for disabled stroke patients is estimated to be in excess of £5 billion in the UK, with stroke patients occupying 25% of long-term hospital beds.
In the US, the annual direct and indirect costs of stroke are estimated to be in excess of $50 billion.
So, should all this go through and be approved by the FDA, I believe the potential for ReNeuron could be vast.
One for the watch list
A quick look on their website showed me that their future plans don't stop at stroke alone.
Among many other diseases they are also looking to combat type 1 diabetes using the same stem cell therapy.
Type 1 diabetes accounts for between 5% and 10% of all diagnosed cases of diabetes. In the US alone, there are approximately one million sufferers, with 30,000 new cases diagnosed each year. The direct and indirect costs of Type 1 diabetes in the US are estimated at $5 billion per annum.
Recombinant insulin injection is the principal current treatment. A small number of patients receive pancreas transplants but donor organ supply is low and the immunosuppressant drug regimen required is problematic.
Current cell transplant treatments suffer a low success rate.
But ReNeuron are working with a Belgian technology partner to develop pancreatic stem cell aggregates, or "organoids", suitable for implantation into Type 1 diabetes patients.
The big idea is that once implanted these organoids should secrete insulin and restore normal glycaemic function offering patients a potential "one-off" cure for the disease.
A joint development programme has been developed with their technology partner to validate the combined technology and take ReN002 forward to clinical proof-of-concept.
ReNeuron are well placed to achieve their aim. And if all goes to plan with the FDA, it could be a very interesting investment.
Until then though, I'm keeping ReNeuron on my watch list.
Watch this space!
Until next time,
Melissa Carroll
for The Penny Sleuth
