VISCOGEL INITIATES PHASE I/II CLINICAL TRIAL FOR ITS NOVEL VACCINE ADJUVANT
Viscogel AB today announced that dosing began in the Phase I/II clinical trial with ViscoGel®, a novel vaccine adjuvant based on the company's proprietary chitosan technology. ViscoGel® has been shown to be safe and effective in pre-clinical studies.
The first part of the Phase I/II trial is a single-ascending dose study with ViscoGel® in 30 healthy volunteers. The second part is a single-dose study in 100 healthy volunteers where ViscoGel® is dosed in combination with a commercially available prophylactic vaccine to evaluate safety and efficacy. The trial is performed at Karolinska Trial Alliance at Karolinska University Hospital in Sweden.
”There is a need for new safe and effective vaccine adjuvants. The positive results from the pre-clinical studies indicate that ViscoGel® can meet these requirements” said Peter Singer, CEO Viscogel AB. ”If the clinical trial results are positive, we believe that ViscoGel® can play an important role in the development of new vaccines.”
Viscogel AB is together with 9 other European companies and academic institutions part of ViVac, a project funded by the European Union’s Seventh Framework Programme. The overall aim of the project is to demonstrate clinical proof-of-concept for ViscoGel® used in prophylactic vaccination. For more information on the ViVac project: www.vivac.se.
Peter Singer, CEO
Telefon: +46 (0)708 - 555 100
About Viscogel AB
Viscogel AB was founded in 2008 to further develop a novel high quality chitosan and viscoelastic gels for medical applications. The company has a unique expertise in chitosan and has developed Viscosan®, which is a medical grade chitosan of a quality previously not available in the market. The company has also patented a novel viscoelastic chitosan hydrogel, ViscoGel®, which can be mechanically processed to small particles. The particles have a large surface area available for interaction with the immune system, can be injected and enable a rapid and improved immune response. Viscogel AB is owned by the founders, management and private investors.
The research leading to these results has received funding from the European Union’s Seventh Framework Programme managed by REA – Research Executive Agency http://ec.europa.eu/research/rea ([FP7/2007- 2013] [FP7/2007-2011]) under grant agreement no 261954.