Bayer's (BAYRY) AskBio Advances Parkinson Disease Study [Yahoo! Finance]
BAYER AG S/ADR (BAYRY)
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Source: Yahoo! Finance
REGENERATE-PD is a phase II study evaluating the efficacy and safety of AB-1005, an investigational adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy for the treatment of moderate-stage Parkinson's disease. Subjects will receive either bilateral image-guided infusion of AAV2-GDNF into the putamen, single dose (active treatment arm) or bilateral partial burr/twist holes (control arm). The trial will include an estimated 87 subjects with study sites located in the United States, the UK and Europe. Enrolment will initially begin in the United States and eventually move on to other sites. The decision to advance the candidate to phase II followed encouraging results from the phase Ib study and the presentation of 18-month data at the American Association of Neurology meeting in April. In January, AskBio reported that the phase Ib study achieved its primary endpoint, which was to evaluate the safety of a one-time bilateral delivery of
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