News

Lipoxen announces that its partner Serum Institute of India has begun Phase I trials of long-acting erythropoietin (EPO)

13 February 2008

Novel product candidate for the treatment of anaemia in patients receiving renal dialysis is based on PolyXen® technology delivery technology

London, UK, 13 February 2008 - Lipoxen PLC, (AIM:LPX) a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and oncology drugs, announces today that its partner, Serum Institute of India, has began dosing patients in a Phase I trial of ErepoXen®, a long-acting EPO. This product candidate, which will be used to treat anaemia in patients receiving renal dialysis, has been formulated using Lipoxen's proprietary PolyXen® delivery technology. Current EPO therapies are generally administered between once and three times a week. The aim of this trial is to demonstrate the benefits of ErepoXen's sustained-release characteristics as compared to current EPO drug products.

The Phase I trial, which is taking place at Veeda Clinical Research Pvt in India, is a randomised double-blind placebo-controlled single dose study. The trial is designed to assess the safety, tolerability and efficacy of EPO formulated using Lipoxen's proprietary PolyXen® technology. This technology is based on polysialic acid (PSA), a naturally occurring polymer which extends a protein's active life, is biodegradable, non-immunogenic and non-toxic, and which is also expected to avoid the toxicity attributed to polyethylene glycol in PEGylated protein drug candidates. The trial will involve 32 healthy adult males, 24 of whom will receive the product candidate while eight will receive placebo, via subcutaneous injection.

It is anticipated that the results of this Phase I clinical trial will be available in April 2008.  Lipoxen's development partner, the Serum Institute of India, is the world's largest producer of vaccines. It is estimated that two out of every three children immunised in the world are vaccinated with a Serum Institute vaccine.

M. Scott Maguire, CEO of Lipoxen, said:

"We are pleased that our partner Serum Institute has initiated this Phase I trial of long-acting erythropoietin which has been formulated using our PolyXen® technology to have an extended duration of activity. This is an important milestone in the development of Lipoxen's overall product pipeline as it is the first clinical trial that Serum Institute has undertaken using a product based on our proprietary delivery technology. In 2007, the overall global market for EPO was worth $9 billion. However, there is a clear demand from patients for improved forms of EPO, which have in particular less frequent dosing and more patient convenience. Today's announcement highlights the growing momentum of Lipoxen's business with the first clinical data for our two most advanced high-value differentiated biologicals expected before mid 2008. In addition, the potential benefits of our portfolio of delivery technologies are attracting interest from a growing list of potential partners and we anticipate signing further licensing deals with pharma and biotech companies who are in need of improved delivery solutions for their biologics during the course of 2008."