ReNeuron Group presents positive pre-clinical data for CTX stem cell line therapy

Stem ReNeuron Group PLC (AIM: RENE) said it is presenting further positive pre-clinical efficacy data for its ReN009 stem cell therapy for peripheral arterial disease (PAD) at the American Heart Association (AHA) Scientific Sessions 2009 in Orlando, Florida, which will run until November 18.

The research was conducted by Professor Paolo Madeddu, chair of Experimental Cardiovascular Medicine and colleagues at the University of Bristol’s Heart Institute, and builds on earlier preliminary work conducted by that group.

In two studies, the researchers tested ReNeuron's lead CTX neural stem cell line, via intramuscular injection, in rats with restricted blood supply to the limbs (ischaemia). A range of doses were used across the studies, from 3,000 to 3 million cells per treatment. A significant and dose-dependent recovery of blood flow to the ischaemic limb was seen as soon as three days after administration, with significantly increased revascularisation of the damaged tissue after 21 days, as measured by increased capillary and arteriole density.  

PAD is a chronic and debilitating disease that progressively restricts blood flow in the limbs, causing cramping, chronic pain and in extreme cases, loss of limb. PAD is commonly associated with other conditions such as diabetes, obesity and stroke. At least 1 in 20 people over the age of 55 have some degree of PAD and it becomes more common with increasing age.

ReNeuron is developing its ReN009 therapy as a non-patient specific stem cell treatment for late-stage PAD, or critical limb ischaemia, in diabetic patients for whom PAD is a side-effect of their diabetes.

Further pre-clinical studies are currently in progress with ReN009, focusing on diabetic models and utilising the newly-developed frozen formulation of the CTX cell line which will be used in future clinical trials. The results of these further studies will be reported in early 2010.

In the meantime, ReNeuron has scheduled meetings within the next month with both the UK Medicines and Healthcare Regulatory Agency (MHRA) and the UK Gene Therapy Advisory Committee (GTAC) in order to discuss and agree certain aspects of the late pre-clinical development plan for the ReN009 therapy. Equivalent meetings are also planned with regulatory authorities in other territories, including the US, ahead of initial clinical trials expected to commence in 2011.

Commenting on the results of the study, Professor Madeddu said: "We are excited by these latest results using the CTX stem cell line, where we have successfully replicated, in a dose-dependent way, the results of a promising initial study in a recognised hind limb ischaemia model. We see real clinical potential in this cell line in ischaemia, where the angiogenic properties of the cell line appear to play a significant role in restoring blood flow in the affected region."