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Lipoxen has received approval to conduct the second Phase I trial

16 June 2008

Lipoxen has received approval to conduct the second Phase I trial of its long-acting erythropoietin (EPO), ErepoXen®, in Canada.

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

London, UK, 16 June 2008 - Lipoxen PLC (AIM:LPX),  a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, announces today it has received approval along with its co-development partner company Serum Institute of India Ltd., to conduct a Phase I trial of ErepoXen®, its long-acting erythropoietin (EPO), in Canada. This trial, which is expected to start in July, is the second Phase I trial for this product. The first Phase I trial was conducted in India, and results showed the product to be well tolerated with the potential to be dosed once monthly thereby providing an improved dosing regime for patients. The global EPO market is currently worth $9 billion and existing EPO therapies are generally administered between once and three times a week.

The Phase I study, which is taking place at Anapharm's, the contract research organisation, clinical research facilities in Canada, is a randomised double-blind, placebo-controlled trial. The study is designed to assess the safety and tolerability of ErepoXen, formulated using Lipoxen's proprietary PolyXen® technology, at single doses of 1.0ug/kg, 2.0ug/kg, 4.0ug/kg or 6.0ug/kg. 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 the results of this Phase I clinical trial will be available in Q4 08.

ErepoXen is formulated using Lipoxen's proprietary PolyXen technology. This technology is based on polysialic acid (PSA), a naturally occurring polymer which is biodegradable, non-immunogenic and non-toxic. Current EPO therapies are generally administered between once and three times a week and this trial aims to demonstrate the benefits of ErepoXen's sustained-release characteristics as compared to current EPO drug products.

M. Scott Maguire, CEO of Lipoxen, said: 

"We are extremely pleased that Lipoxen has received approval by the Canadian authorities to conduct this second Phase I trial of ErepoXen® for the US and Canadian market, our long-acting erythropoietin which has been formulated using our PolyXen® technology to have an extended duration of activity. We look forward to this trial strengthing the clinical data available on ErepoXen® and building upon the recently announced positive Phase I results which have shown the product candidate to be safe and well tolerated with the potential to be administered on a once a month basis and competing in the $9 billion EPO market. Today's announcement highlights the growing momentum of Lipoxen's business, and the key role our portfolio of proprietary delivery technologies is expected to play in the generation of further deals and R&D collaborations throughout 2008."

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