Lipoxen's Bio-Polymer Technology Granted Important US Patent

Published: Jan 14, 2010

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, announces today that it has been granted a new US patent for its PolyXen technology. This technology is based on polysialic acid (PSA), (a polymer occurring naturally in humans) which extends a protein’s active life, is biodegradable, non-immunogenic and non-toxic, and which is also therefore expected to avoid the toxicity attributed to polyethylene glycol in PEGylated protein drug candidates.

Polysialylation of therapeutic proteins i.e. the attachment of PSA on these molecules, is often hampered by random attachment of PSA molecules onto the protein. As a result, attached PSA can mask the active site of the therapeutic. In many cases, masking of activity can lead to complete loss of the protein's therapeutic function.

To avoid such problems, polysialylation is targeted on a specific domain on the protein, away from the active site. To that end, a specific domain is created by the introduction of a cysteine on the protein molecule (away from the active site) through protein engineering.

The US granted patent refers to the preparation of the PSA-linker-SH (cysteine)-protein construct. It has been shown that a number of therapeutic proteins which have been polysialylated, retain most of their activity as well as all the advantages of polysialylation i.e. improved drug performance and longer circulation time of the drug in the body.

In summary, the patent identifies that polysialylation, Lipoxen's PolyXen platform, is more effective in improving the therapeutic function of protein drugs.

Commenting on the patent grant, M. Scott Maguire, CEO of Lipoxen, said: “The new patent grant on this natural polymer which extends the active life of protein enhances our patent position in the world’s largest pharmaceutical market and further supports our drive to become a leading innovator within the next generation biologic drug space.

Lipoxen has two potential billion dollar block-buster products in clinical development, SuliXen, a long acting insulin and ErepoXen, a long-acting erythropoietin (EPO) both of which are based on this PolyXen technology. We are confident that this new patent will strengthen our commercial position as well as our capability to collaborate with partners.”

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