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ErepoXen Phase II Trial Commences

01 March 2010

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, is pleased to announce that its partner, the Serum Institute of India ("Serum Institute"), has now commenced first dosing of patients for Lipoxen's expanded Phase II trial of ErepoXen® in India.

Lipoxen's ErepoXen product candidate is an enhanced polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anaemia caused by chronic renal (kidney) failure or chemotherapy. ErepoXen uses Lipoxen's PolyXen® platform technology to attach polysialic acid (PSA), a polymer of sialic acid (a biodegradable sugar that is found naturally in the human body) to protein drugs.

The trial is an open label Phase II ICH-GCP compliant trial involving 30 patients with anaemia, across 6 trial centres in India. The primary endpoints of the trial are improved red blood cell count, reticulocytes, hemoglobin and hematocrit. Secondary endpoints will measure safety, a reduction in the frequency of injections versus current EPOs, and immunogenicity. Clinigene International Ltd, a Biocon group company based in Bangalore is the contract research organization running the trial. Results on this trial are scheduled to be reported early Q3 this year.

As reported in early February, the Serum Institute agreed to accelerate the product candidate towards marketability by expanding the planned trial into a fully integrated Phase II US FDA compliant trial and to meet the additional costs associated.

Commenting on the Phase II trial, M. Scott Maguire, CEO of Lipoxen, said: "The commencement of our Phase II ErepoXen trial with the Serum Institute under European regulations in India is a very exciting step forward. EPO is a currently $9B drug and is injected 1-3 times per week. Our EPO is designed to last for one month so we are very excited about moving this potential blockbuster candidate into patient trials having had a successful Phase I trial. Not only will the trial measure the potential benefits of our enhanced EPO product candidate, but positive results will assist Lipoxen to execute further licensing deals that combine our versatile PolyXen® platform technology with existing protein drugs."

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