AMSTERDAM, May 14 SynCo Bio Partners B.V., a leading GMPbiopharmaceutical manufacturer, announced today that it has completed themanufacture and release of ActoGeniX' drug substance AG011 for use in a PhaseII clinical trial with ulcerative colitis patients.
ActoGeniX is focused on the development and commercialization ofActoBiotics(TM), a novel class of protein-based biopharmaceuticals that canbe orally administered. The Company's lead product AG011 is an ActoBiotic(TM)for treatment of inflammatory bowel disease and has previously beensuccessfully tested in a Phase I clinical trial with Crohn's disease patients.
To provide the AG011 drug product required for the Phase II studies, dueto start this summer, SynCo has developed and scaled up the manufacturingprocess involving cultivation, purification and lyophilisation of AG011.Although the project involved several parties, working virtuallysimultaneously on different aspects, the GMP batches were produced within theagreed timelines.
Announcing the successful completion of the project, Pierre Warffemius,CEO, said, "Having ActoGeniX choose us to manufacture the GMP batches fortheir Phase II clinical trials is a clear endorsement of our growingreputation for manufacturing live biopharmaceuticals. The fact that we wereable to work on a multi-agency project and deliver the drug substance on timeis also an excellent example of project management capabilities."
Mark Vaeck, CEO of ActoGeniX, "The move from Phase I to Phase II clinicaltrials is a critical step for ActoGeniX so it was imperative that we workedwith a GMP-accredited contract manufacturing organisation that had a proventrack record in developing processes for biopharmaceuticals, as well ascommercial manufacturing capabilities."
ActoGeniX will, in the coming weeks, file the regulatory applications toobtain approval for the start of its AG011 clinical trial during this summer.ActoGeniX also plans to start a Phase II study with the same product inCrohn's disease patients in the course of 2009. For more information aboutthe product please visit http://www.actogenix.com
Issued on behalf of SynCo Bio Partners by De Facto Communications
About SynCo Bio Partners B.V.
SynCo Bio Partners is a GMP-licensed bulk drug substance and finalproduct CMO with in-depth clinical and commercial production experience withmammalian and microbial systems. This experience has been acquired bydeveloping new production processes for a number of international clients andproducing a wide variety of different vaccines, live bacterial products andrecombinant proteins in our state-of-the-art, GMP-licensed facilities in thelast seven years.
Financially stable and focused solely on biopharmaceuticals, SynCo BioPartners acts as a strategic, long-term partner delivering your product ontime and to the highest quality standards. All our staff are committed toexceeding customer expectations and believe that taking a truly collaborativeapproach to manufacture is the key to a successful outcome.
Also visit http://www.syncobio.com
About ActoGeniX N.V.
ActoGeniX is a biopharmaceutical company focused on the development andcommercialization of ActoBiotics(TM), a novel class of biopharmaceuticals forthe targeted treatment of severe gastrointestinal (GI) diseases, metabolicdiseases, immune disorders and allergies. ActoBiotics(TM) can be orallyadministered and are designed to be safer and more effective than injectablebiopharmaceuticals. ActoGeniX's initial focus is on GI diseases and its leadproduct for the treatment of Crohn's disease and ulcerative colitis hasalready been successfully tested in a phase 1 clinical trial.
ActoGeniX was founded in 2006 as a spin-off from VIB and GhentUniversity. The Company is headquartered in Ghent (Belgium) and employs closeto 40 employees, half of whom are PhD's,