Reneuron (RENE.L) Files 2 Clinical Trial Applications in UK

Up to you in the UK if you want to get involved.  Ask about the intramuscular injection site, why there?
http://www.proactiveinvestors.com/columns/scimitar-equity/2101/reneuron-renel-files-2-clinical-trial-applications-in-uk-2101.html

ReNeuron submitted 2 applications to UK regulatory authority to commence multi-site ischemic stroke P2 clinical trial to examine efficacy of ReN001 and ReN009 for Critical Limb Ischemia (CLI).

The ReN001 ischemic stroke trial is designed to recruit from a well-defined population of patients between 2 and 4 months after their stroke, which they believe will be the optimum treatment window for the therapy.

The ongoing PISCES study with ReN001 continues on plan following the commencement of treatment of patients in the penultimate dose cohort last month, there remain no cell-related serious adverse events reported in any of the patients treated to date. The independent Data Safety Monitoring Board for the study will shortly make its recommendation regarding treatment of the remaining patients in the penultimate dose cohort. In June of this year, interim data from the PISCES study from the first 5 patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan. Reductions in neurological impairment and spasticity were observed in all 5 patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

RENE.L also submitted application to UK regulatory authority to commence a P1 clinical trial of ReN009 stem cell therapy for critical limb ischemia (CLI). These patients will be administered via straightforward intramuscular injection of the cells.

The Bottom Line:  But … it is a competitive trial and market arena … Athersys (ATHX) is also pursuing a P2 clinical trial in ischemic stroke. ATHX believes its MultiStem therapy can help limit the associated damage that occurs post ischemic stroke by down-regulating the immune response that follows. ATHX is now conducting a 140-patient trial with data expected in 2H13. MultiStem is a drug-like stem cell product that is produced by obtaining a special class of stem cells from healthy, consenting donors. These cells express proteins and other factors involved in tissue repair and immune system regulation and act through multiple mechanisms, such as protecting damaged or injured cells, reducing inflammation and promoting new blood vessel formation in areas of ischemic injury.  Aastrom (ASTM)is recruiting for its P3 CLI trial which is on-going and headed to completion. This trial will assess the efficacy and safety of ixmyelocel-T in CLI patients. REVIVE will be conducted in the United States across 80 sites and is targeting an enrollment of just under 600 no-option CLI patients. REVIVE represents the largest randomized, double-blind, placebo controlled, multicenter study ever conducted in patients with CLI.  Pluristem (PSTI) reported CLI P1 results in 11/11 of 27 patients in Germany. The PLX-PAD cells therapy failed in 4 of the 27 patients, giving a rate was 85.2% after 12 months for the PLX-PAD cells therapy.  However, little has been heard since … stated it was planning to conduct its P2/3 trials for CLI in the 2H11.