Guildford, UK-based ReNeuron says that results from a preclinical study stipulated by the US Food and Drug Administration on its ReN001 stem cell therapy reached its end-point with no significant or unusual adverse safety effects observed so far in either control or treatment groups.
The company says it is encouraged by the results both from this study and from the others undertaken in support of the Investigation New Drug application. Based on these results, the UK firm confirms that it remains on track to submit the required IND data package to the FDA in the final quarter of the year.
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