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

LONDON - Lipoxen plc, a bio-pharmaceutical company specializing in the development of high-value differentiated biologicals, vaccines and siRNA delivery, announced in a press release 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.

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."