News

Lipoxen's first clinical candidate, SuliXen, enters Phase I trials

28 January 2008

London, UK, 28 January 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 a Phase I trial of SuliXen, its long-acting insulin candidate for Type 1 and Type 2 diabetes, has started. SuliXen is the first of Lipoxen’s products to enter clinical trials.

The exploratory Phase I study, which is taking place at the Federal State Center of Endocrinology in Moscow, will involve 12 healthy volunteers. In a crossover design, each volunteer will receive two doses of SuliXen (0.1IU/kg and 0.3IU/kg) in comparison with a long-acting, insulin analogue – insulin glargine (Lantus, Sanofi -Aventis) dosed at 0.2IU/kg. The study is expected to report first results in the second quarter of 2008. SuliXen, a long-acting insulin, 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, and is expected to avoid the toxicity attributed to polyethylene glycol in PEGylated protein drug candidates.

M. Scott Maguire, CEO of Lipoxen, said:

“We are pleased that the Phase I trial of SuliXen has started, this is an important milestone in the development of the Company’s own drug pipeline. With the World Health Organisation expecting there to be over 300m diabetes sufferers world wide by 2025, there is a clear market need for alternative insulin formulations such as SuliXen. In addition to insulin, Lipoxen anticipates that its long-acting erythropoietin (EPO) candidate will enter Phase I clinical trials shortly. The early months of 2008 are expected to be a very important period for Lipoxen as we generate the first clinical data on our most advanced high value differentiated biologicals. In addition, to developing our own product pipeline, we are continuing to work to sign further licensing deals with pharma and biotech companies who are in need of improved delivery solutions for their biologics."

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