www.reneuron.com
ReNeuron is a leading, clinical-stage stem cell business. Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron makes “excellent progress” with PISCES stem cell trial
Stem cell firm ReNeuron (LON:RENE) is making “excellent progress” with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients, according to Merchant Securities.
The broker added that ReNeuron’s interim statement “is the most confident yet that we have seen from the company in relation to the PISCES trial and read across to its other programmes”.
ReNeuron said that five patients in its 12-patient trial have so far been treated. Three of these, in the first dose cohort, are now through their 12-month, nine-month and six-month follow -up points, respectively. The first patient treated in the second dose cohort is through his one month follow-up point.
The firm also reported that there have been no cell-related adverse events, and that when the independent Data Safety Monitoring Board (DSMB) met late last month its review of data from the first four patients showed no deterioration in health as a result of the ReN001 treatment.
ReNeuron said that it expects to treat all the remaining patients in the PISCES clinical trial over the course of 2012 and, after seeking advice from regulatory authorities, it plans to begin a Phase II efficacy study in 2013.
“We are greatly encouraged by the results seen in the PISCES clinical trial to date,” said Michael Hunt, ReNeuron’s chief executive officer. “Although it is the highest dose in this study that we are likely to evaluate for efficacy in future trials, we are pleased that the treatment appears to be well-tolerated at the lower doses tested thus far.”
In its half-year results, covering the six-month period to September 30, ReNeuron confirmed that it planned to launch in H2 2012 a Phase I/II clinical trial application for its ReN009 stem cell therapy for critical limb ischaemia. Here, confirmatory pre-clinical efficacy studies have been completed with positive results, while long-term pre-clinical safety studies are approaching completion.
The firm also has pre-clinical studies underway for its ReN003 stem cell therapy for retinitis pigmentosa, following a licensing agreement with Schepens Eye Research Institute. A Phase I/II clinical trial application is planned for mid-2013.
ReNeuron reported a loss for its first half of £3 million (2010: £2.5 million). Cash used for operations during the period was £3.2 million (2010: £2 million). At the end of September, the firm had cash and cash equivalents of £6.5 million (September 30 2010: £3.5 million).
Shares in the firm were down 9.65 per cent to 5.15 pence in late-morning trading today, which suggests today’s results were an opportunity for profit takers to sell. Only six weeks ago, ReNeuron’s shares were changing hands for less than 3.5 pence each.
Merchant Securities pointed out that, given the withdrawal of bellwether stem cell player Geron from embryonic stem cell research, the adult stem cell space has “become much more attractive”.
The broker has a ‘buy’ rating for the shares along with a target price of 33 pence.
