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European Patent Granted

08 February 2010

Lipoxen's Polysialylated G-CSF StimuXen™ Technology Granted European Patent

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, announces that it has been granted patents for its Polysialylated GCSF StimuXen™ Technology in six European territories, including the UK, Germany, France, Spain, Italy and Switzerland.

This technology is based on polysialic acid (PSA, a polymer occurring naturally in humans), which extends a protein's active life. PSA is biodegradable, non-immunogenic and non-toxic and is also therefore expected to avoid the toxicity attributed to polyethylene glycol (PEG) in PEGylated protein drug candidates.

StimuXen™ uses Lipoxen's patented PolyXen™ technology to attach polysialic acid onto the N-terminal of G-CSF to produce polysialylated G-CSF. The patent application related to it is recent and has now been granted in Europe. Preclinical work with StimuXen™ has shown improved pharmacokinetics and pharmacodynamics which are similar to those of the longest-acting version of G-CSF on the market whose patent expires in 2015. G-CSF generated global sales of $5.2B in 2008.

How it works
The G-CSF (granulocyte-colony stimulating factor) stimulates the bone marrow to produce more white blood cells (WBC).

A major side effect of chemotherapy is a reduction in the number of WBC which can lead to a patient's reduced ability to fight infection, consequent to which chemotherapy may be postponed or the dose lowered, neither outcome being optimal for the preferred treatment. Prescription of G-CSF acts to protect the body's level of WBC during chemotherapy and is usually administered daily for up to 14 days.

The leading currently available G-CSF therapy is administered once with each cycle of chemotherapy. Lipoxen expects that the improved StimuXen™ GCSF will have a similar treatment profile.

Commenting on the patent grant, M. Scott Maguire, CEO of Lipoxen, said: "We are confident that StimuXen™, which is currently in pre-clinical development, could be as successful as our two potential billion dollar blockbuster 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."

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