Proactive investors

Lipoxen Plc

Lipoxen granted EU patent for polysialic acid technology StimuXen

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of differentiated biologicals, vaccines and siRNA delivery, said it has been granted patents for its Polysialylated G-CSF StimuXen proprietary technology in six European territories: the UK, Germany, France, Spain, Italy and Switzerland. The technology aims at protecting the body’s level of white blood cells which is particularly beneficial in chemotherapy patients.

This technology is based on polysialic acid, or 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, Lipoxen said. G-CSF generated global sales of US$5.2B in 2008.

The G-CSF (granulocyte-colony stimulating factor) stimulates the bone marrow to produce more white blood cells. A major side effect of chemotherapy is a reduction in the number of white blood cells 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 white blood cells 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 G-CSF will have a similar treatment profile.

CEO M Scott Maguire said: "We are confident that StimuXen, which is currently in pre-clinical development, could be as successful as our 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."

Lipoxen has three proprietary patented technology platforms: PolyXen for extending the efficacy and half life of biologic drugs, ImuXen for creating new vaccines and improving existing vaccines and iRNAblate for the delivery of siRNA, short for small interfering RNA or silencing RNA.

Lipoxen has multiple drug and vaccine programmes in development.  Two products are in clinical development, SuliXen, a long acting insulin and ErepoXen, a long-acting erythropoietin (EPO). Lipoxen's preclinical pipeline includes vaccines against HIV, influenza and malaria and an exclusive license deal with Baxter Healthcare for Factor VIII.

The company out-licenses its proprietary technologies to biopharmaceutical companies that have strong manufacturing and marketing capabilities.  Lipoxen’s commercial agreement partners currently include Baxter, Schering-Plough, the Serum Institute of India Ltd, Genentech, and Genzyme. Furthermore, Baxter, the company's third largest shareholder, and management led the £2.9 million fundraising that the company announced in May 2009.