ReNeuron Group (AIM: RENE) has signed two further clinical grade stem cell manufacturing contracts with Angel Biotechnology Holdings (AIM: ABH) in support of ReNeuron's recently approved first-in-man clinical trial with its ReN001 therapy for stroke patients.
Under these contracts, Angel will manufacture further drug substance lots of ReN001 stem cells for administration to patients in the trial, along with the provision of manufacturing process validation services. The cost of the drug product manufacture is being met by a recently-awarded grant from the UK Government's Technology Strategy Board, under its Regenerative Medicine Programme.
The PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In the Phase I trial, ReNeuron's ReN001 stem cell therapy will be administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial.
“We are pleased to continue to work with Angel as our chosen contract manufacturing partner for the PISCES clinical trial for ReN001 in stroke. Angel has consistently demonstrated its strong expertise in the field of regulatory-compliant cell manufacture, meeting ReNeuron's needs for this important first-in-man study,” said ReNeuron chief executive Michael Hunt.
The trial will be the world’s first to use expanded neutral stem cells in this indication, the company said.
Back in September, the two companies agreed to perform work to further develop and manufacture clinical-grade lots of a second-generation formulation of ReNeuron's CTX stem cell line for subsequent pre-clinical and clinical applications. The CTX cell line forms the basis of ReNeuron's ReN001 therapy for stroke and its ReN009 therapy for peripheral artery disease.
ReN001 has been shown to reverse the functional deficits associated with stroke disability when administered several weeks after the stroke event in relevant pre-clinical models of the condition. The group secured approval to commence a first-in-man clinical trial from the UK Medicines and Health Products (MHRA) in January 2010.
In the first-in-man trial, 12 patients will receive the ReN001 therapy from between six to 24 months after their stroke. The phase one trials are now underway and if ultimately shown to be safe and effective clinically, ReN001 should become a significant new treatment option for stroke survivors, offering the potential for a degree of recovery of function in disabled stroke patients. Various independent regulatory administrative bodies play a part in the sign-off required along the way, so short term news flow should not be expected, with the phase one trial taking between 24 and 36 months to complete.
About half of the 50 million stroke survivors worldwide are left with a disability, while the annual costs of caring for such patients amount to £5 billion in the UK and US$50 billion in the US.
Disclosure: The author holds no positions in the company