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Retroscreen Conducts Landmark hVIVO Human Challenge Model Study Of AL-8176 In RSV For Alios BioPharma


7/28/2014 8:22:35 AM

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Retroscreen Virology Group plc (AIM: RVG), the pioneer of hVIVO Human Challenge Models (“HCMs”) of disease, acknowledges the announcement by Alios BioPharma Inc. of positive results from a landmark human viral challenge study of its oral anti-RSV nucleoside analog AL- 8176 in Respiratory Syncytial Virus (“RSV”) infection that was conducted by Retroscreen. This study is considered to be a major endorsement of the clinical utility of Retroscreen’s hVIVO platform, in rapidly establishing proof of concept and dose-ranging for investigational new drugs early on in their development lifecycle.

The study was a randomized, double-blind, placebo-controlled Phase 2 challenge study of AL- 8176 in healthy adult volunteers, who were infected intranasally with RSV. AL-8176 achieved its primary and secondary endpoints of reduction in viral load (p<0.0002), and improvement in symptom scores (p<0.02), as compared to placebo. AL-8176 was well tolerated, with no discontinuations of study drug and no clinically significant laboratory abnormalities. This viral HCM study was conducted by Retroscreen at its purpose built, state-of-the-art clinical quarantine unit in London, UK. It utilised an adaptive design and enrolled a total of 62 subjects across 3 quarantine periods. The study started in January 2014 and was conducted by Retroscreen in a little under 6 months.

Kym Denny, Chief Executive Officer, commented, “This study of Alios’ AL-8176 product for RSV infection, conducted by Retroscreen in just under 6 months, highlights hVIVO's ability to surpass field-based studies in producing clean compelling data in an accelerated timeframe, through targeted subject recruitment and defined timing of infection. The ability to accelerate the development of new drugs underpins our expansion into new HCMs, including for respiratory diseases such asthma and Chronic Obstructive Pulmonary Disease (COPD)”.

For further information please contact:
Retroscreen Virology Group plc +44 207 756 1300
Kym Denny (CEO)
Graham Yeatman (FD)

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