The European Union Patent Office (EPO) has granted UK stem cell experts ReNeuron patent protection for three key human neural stem cell lines.
The patents cover the composition, production and use of three neural stem cell lines and their use as a treatment for stroke, Huntingtons disease, Alzheimers disease, traumatic brain injury and Creutzfeld-Jacob disease (CJD).
The claims also cover the use of these cells in non-therapeutic applications such as cell-based screens for testing neurological drug candidates.
"We were not too affected by the wider patent issues involving human embryonic stem cells because we have produced cell lines from tissue samples and made that applications on that basis," said Michael Hunt, CEO of ReNeuron.
"We have made equivalent applications in the US which are currently going through the application process."
The three lines covered by the patent are ReN001, ReN005 and an unnamed-as-yet back up cell line that Hunt believes may end up in a therapy in due course.
ReNeuron has filed an investigational new drug (IND) with the US Food and Drug Administration (FDA) to study ReN001 as a treatment for stroke.
The FDA has put the application on hold, as
previously reported in DrugResearcher.com, until the company provides further information.
"We are continuing our dialogue with the FDA and running preclinical experiments - most started prior to the application - to fill in the missing information the regulators have requested," said Hunt.
He continued by explaining that the issues revolved around the potential pharmatoxicity of stem cell lines, especially as they would be going into the brain with the regulators wanting to make sure the treatment is as safe as possible before allowing it into humans.
"The studies we have completed thus far subsequent to the IND have all showed that the cells are behaving themselves."
Hunt believes that the cells are less predisposed to the pharmatoxicity issues surrounding human embryonic stem cells (HESCs) such as tumourigenesis as they are further differentiated than HESCs.
"One issue is that in healthy brain the cells don't hang around very long, so we have to prove the safety in a lesion model that we have subjected to a stroke and can show the safety and efficacy in that model," he said.
"We are confident we can get this through the regulator and into patients in due course - the FDA is a cautious but receptive regulator," he continued.
ReN005 is at an earlier stage of development, and while the company has generated some efficacy data in the laboratory Hunt said that they were yet to hit any major milestones but that there was progress being made in the background.
He also mentioned that the company would probably be looking to conduct clinical trials of ReN005 in the UK.
Hunt said that the company has licensed cell lines to various organisations and made its ReNCell CX and ReNCell VM cell lines and cell media available to the stem cell research community for non-therapeutic applications via a licensing agreement with Millipore.
He was keen to stress that while these agreements obviously helped the company's finances the company was
"here to drive cell therapies and take our candidate lines into humans as therapies."
