SGS clinical research to optimize the fight against the influenza pandemia with novel virus agent for clinical trials.
SGS, a leading life sciences pharmaceutical clinical and bioanalytical contract solutions provider, today announced the forthcoming availability of a new strain of influenza virus for use as a challenge agent in clinical trials.
The synthetic virus may be used to test the efficacy of both novel influenza drugs and vaccines in healthy volunteers.
The new agent is a H3N2 type virus, which represents one of the common current circulating strains of influenza of a pandemic origin. Its manufacture has been undertaken by SGS in accordance with Good Manufacturing Practice to ensure that strict regulatory guidelines in both the US and EU (FDA and EMA) are met. The virus is currently undergoing an array of both adventitious and purity tests. It is anticipated that final safety and activity data from the first-in-human studies using the virus will be announced in a presentation at the World Vaccine Congress, to be held in Washington DC, in April 2017.
“This announcement marks a significant milestone for our work in infectious disease research, and we believe this new strain will offer unique advantages over other influenza challenge agents,” commented Adrian Wildfire, SGS Project Director, Infectious Diseases and Viral Challenge Unit. “The new H3N2 strain was selected from a number of differing isolates of influenza following extensive comparative testing, after it was shown to be associated with a moderate, uncomplicated illness, and a full recovery.”
“The combination of the active H3N2 virus and SGS’s dedicated testing facilities will provide valuable assistance in the fight against the influenza pandemic. This will result in measurable benefits for our clients by reducing the timelines and costs of new compounds brought to market,” added Jean Luc Marsat, SGS Clinical Research’s Managing Director.
SGS has experience of the use of influenza challenge agents within its viral challenge unit, and previous studies have allowed products to advance to Phase III studies without the need for Phase IIb trials in the community. Challenge trials are proving to be of increasing interest to companies wishing to obtain high quality data for efficacy and effectiveness prior to designing large, late phase studies, to better inform the trial design and subsequent performance of their products.
Located in Antwerp’s Stuivenberg Hospital, Belgium, SGS’s fully accredited, containment level 2, 20 bed human challenge unit provides full isolation capabilities and offers an entire range of services for any challenge trial performed with the new influenza agent.
SGS provides biopharmaceutical companies with R&D solutions across Europe and the Americas with Phase I to IV clinical trial management services, encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy. In addition to its clinical research services, SGS leverages its wholly-owned global network, with 21 laboratories offering contract analytical and bioanalytical services.