PRV-101 is a polyvalent coxsackievirus B (CVB) vaccine licensed from Vactech, Ltd., which Provention is developing as a potential vaccine for acute coxsackie infection and for the potential prevention of up to 50% of worldwide type 1 diabetes (T1D) cases.
PRV-101 is currently in an IND-enabling stage prior to initiation of first-in-human studies. Provention plans to initiate a clinical program for PRV-101 beginning with Phase 1 safety, tolerability and proof-of-mechanism studies in adults and children, followed by a proof-of-concept study.
Prevention of Acute Coxsackie Infection and T1D
T1D is the end result of immune-mediated destruction of the insulin-producing beta cells of the pancreas and is one of the most common and serious chronic diseases occurring in childhood. CVB infection is very common and is responsible for various symptoms and complications ranging from mild respiratory disease, gastrointestinal disturbances and hand-foot-mouth disease to life-threatening cardiomyopathy and meningitis.
Longitudinal studies of more than 200,000 children studied for up to two decades in Finland by Vactech and its collaborators identified CVB infection as a likely environmental trigger in the onset of T1D and T1D-associated celiac disease. The T1D association with CVB infection has been observed in additional independent cohorts in 15 countries, including North America and Australasia.
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