ReNeuron Announces Filing IND Application to the FDA for ReN001
News Dec 08, 2006
ReNeuron Group has announced the filing of its first Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to commence initial clinical studies in the US with ReN001, its stem cell therapy for stroke.
The company believes that this filing is a key milestone in ReNeuron's history and the world's first such application concerning a neural stem cell treatment for a major neurological disorder.
Stroke is the single largest cause of adult disability in the developed world. Over 130,000 people suffer a stroke each year in the UK, and over 700,000 people in the US.
ReNeuron's ReN001 stem cell therapy seeks to treat those patients who have suffered a stroke and have been left disabled by it. These patients constitute approximately one third of the total stroke patient population.
According to ReNeuron- existing treatments for stroke in the chronic phase are primarily focused on the prevention of recurrent strokes. The annual health and social costs of caring for disabled stroke patients is estimated to be in excess of £5 billion in the UK, with stroke patients occupying 25 per cent of long term hospital beds.
In the US, the annual direct and indirect costs of stroke are estimated to be in excess of US$50 billion.
Following approval of the IND, the initial clinical study will be conducted under the direction of Professor Douglas Kondziolka MD, MSc, FRCS, FACS at the University of Pittsburgh Medical Center.
The initial Phase I study with ReN001 will be an open label study, with two dose levels, in disabled stroke patients. The primary objective of the study will be to monitor the safety profile of the treatment.
Preliminary efficacy measures will also be recorded, however, to provide an indication of therapeutic potential ahead of further efficacy studies in a larger cohort of patients once the safety of the ReN001 therapy has been confirmed.
Professor Kondziolka at the University of Pittsburgh Medical Center, commented: "Our team has participated in the design of ReNeuron's first clinical study and we are excited about the potential this research offers in the field of brain repair. This study seeks to address the immense problem of disability following stroke, for which there are few treatment options."