Guildford, UK, 14 March 2014: ReNeuron Group plc, a leading UK-based stem cell therapy company, welcomes today’s announcement from the UK Government Department of Health of the launch of the Early Access to Medicines Scheme (EAMS).
The scheme is intended to encourage the early uptake of novel therapies, thereby promoting investment in medical research in the UK and strengthening its science, research and drug development industry. The scheme seeks to enable faster patient access to medicines for the treatment of life threatening or seriously debilitating conditions where there are currently no available treatments.
ReNeuron’s primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need, for conditions such as stroke, critical limb ischaemia and retinitis pigmentosa. The Company will therefore explore the applicability of the EAMS to its own therapeutic candidates, potentially enabling its treatments to be offered to patients in the UK through the NHS at an earlier stage in the drug development cycle and providing greater certainty regarding the pathway to full market approval and subsequent treatment uptake within the NHS.
Today’s announcement from the UK Government follows similar initiatives in other countries. In 2012, the US Food and Drug Administration implemented its Breakthrough Therapy Designation programme, designed to increase the speed at which novel therapies are developed and reviewed in the US. Last year the Japanese Government enacted legislation to provide for an accelerated market approval process for regenerative medicine treatments in that territory.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are supportive of this morning’s announcement from the UK Government in respect of the Early Access to Medicines Scheme. We are seeing a clear push from governments and regulatory authorities in major territories around the globe to establish robust but much faster and more efficient routes to market for novel therapies in areas of unmet medical need. Given ReNeuron’s focus in these areas, we see the business and the patients who may benefit from its treatments as prime beneficiaries of these global developments.”
Please follow the link below for today’s announcement from the Department of Health: https://www.gov.uk/government/news_cutting-edge-drugs-to-be-fast-tracked-to-patients
ReNeuron is a leading, clinical-stage cell therapy development business. Based in the UK, its primary objective is the development of novel cell-based therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional immunosuppressive drug treatments. The Company’s lead therapeutic candidate is its ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. This treatment is currently in clinical development. The Company is also developing stem cell therapies for other conditions such as critical limb ischaemia, a serious and common side effect of diabetes, and blindness-causing diseases of the retina.
ReNeuron is also advancing a proprietary platform technology to exploit nanoparticles (exosomes) secreted by stem cells as potential new drug candidates targeting indications in tissue repair, fibrosis and cancer.
ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.