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Mucosis Starts Clinical Study with its Lead Product, FluGEM
Dutch biotechnology company Mucosis B.V. today announced the start of a Phase 1 clinical study with its lead product FluGEMTM, a novel improved influenza vaccine for the elderly. It is the first-ever study in man with a vaccine candidate based on MimopathTM, a proprietary platform technology for developing more potent vaccines.
The clinical study will be conducted in conjunction with the Centre for Human Drug Research (CHDR; Leiden, the Netherlands). It is designed to test the safety and tolerability of FluGEMTM, as well as the mucosal and systemic immune responses including correlates of protection against influenza viruses. The trial will involve FluGEMTM being administered both as droplets in the nose and by intramuscular injection.
Mucosis has evaluated FluGEMTM for safety and toxicity in well-accepted animal models, and found it to be safe at all doses tested. Moreover, preclinical results show an induction of robust mucosal and systemic immunity and superior protection from an influenza challenge.
"We are very pleased with the on-schedule initiation of this Phase 1 study," said Govert Schouten, CEO of Mucosis. "This is an important step towards realizing our ambition of taking an improved flu vaccine to the market. In addition, this study will validate MimopathTM as a platform technology for the development of new vaccines that provide better and broader protection".
The enrollment of volunteers for the trial has been initiated and immunizations are scheduled to start in the next weeks. The vaccine will be tested in 90 adult and 60 elderly trialists. Interim top-line data from the study are expected to become available before the end of 2011. The clinical study is financially supported by Agentschap NL, an agency of the Dutch Ministry of Economic Affairs, Agriculture and Innovation.
About Mucosis - www.mucosis.com
Mucosis B.V. is a Dutch biotechnology company with a proprietary platform technology, MimopathTM , on which it develops mucosal vaccines with improved efficacy. Mucosis's lead products are FluGEMTM, a vaccine to prevent influenza; PneuGEMTM, a vaccine to prevent diseases caused by pneumococcal bacteria; and SynGEMTM, a vaccine to prevent RSV viral infection. MimopathTM -based vaccines can be administered needle-free in the nose and mouth, evoking a more natural immune response with a broader base of protection.
About MimopathTM technology
The MimopathTM technology is based on Lactococcus lactis, a safe bacterium commonly used in the food industry. Mucosis has developed a robust technique to formulate the L. lactis bacteria into non-living bacterial-like particles (BLPs) that can be loaded with antigens from viral, bacterial, parasitic or tumor origin. The antigen-covered BLPs form a vaccine that can be delivered into the nose or mouth, without the need for a needle. These vaccines raise protective immunity by activation of both the innate and the adaptive immune system.
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