Date: 2012-05-16
Type of information: Production agreement
Compound: ReN001
Company: ReNeuron (UK) Angel Biotechnology (UK)
Therapeutic area: Cerebrovascular diseases
Type agreement: manufacturing
production
Action mechanism: stem cell therapy
Disease: stroke
Details: ReNeuron has signed a new cell manufacturing contract with Angel Biotechnology, a biopharmaceutical contract manufacturer, to perform GMP drug product manufacturing services to serve the remaining part of the PISCES Phase I clinical trial of ReNeuron’s ReN001 stem cell therapy for stroke. The final patient in the second dose cohort of the PISCES study was treated last month, as scheduled. The Glasgow clinical site has also identified potentially eligible patients for all of the remaining two dose cohorts in the study. Two further UK clinical sites are in the process of being approved to recruit patients into the PISCES study should this be necessary to meet recruitment targets. It is envisaged that these further clinical sites will also participate as centres in a Phase II clinical trial with ReN001 in due course.
As recently reported, the Company therefore expects that, subject to a continuing lack of cell-related adverse events and affirmative Data Safety Monitoring Board advice, the remaining dose cohorts in the PISCES study will have been treated within the next twelve months, leaving the Company on track to submit an application for a Phase II clinical study with ReN001 during the course of next year.
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