ReNeuron Group PLC (LON:RENE) said dosing has now begun in the US for the expanded phase IIa trial of its hRPC cell therapy for the degenerative eye condition retinitis pigmentosa (RP).
Up to a further nine people will be given higher dose levels under a revised protocol at sites in America and the UK. Ten patients have already taken part in this stage of the study.
ReNeuron said it expects to present further data over the next 12 months and it believes it will be able to compile enough clinical evidence in that time to seek approval in the second half of next year for a single pivotal clinical trial.
The firm’s RP programme has been granted orphan drug designation in both Europe and the US that potentially cedes it a significant period of market exclusivity over the product.
The US Food & Drug Administration (FDA) has also given the hRPC treatment fast-track status, which means it may be eligible for accelerated approval.
The hRPC update was part of a broader trading statement delivered ahead of ReNeuron’s annual meeting in which it reiterated its belief it will see increasing industry interest in its exosomes programme translate into further collaborations.
It has already signed two research evaluation agreements with companies interested in exploring the potential of the technology.
“In addition, we expect to be able to sign further collaboration agreements, currently under negotiation, in the near term,” the company added.
In very simple layman’s terms, exosomes are used by cells to communicate and are released as tiny “nano-bubbles” into the body to do so. The AIM-listed stem cell specialist has created its own line to deliver a drug payload.