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Lipoxen announces positive Phase I data with its long-acting insulin candidate, SuliXen

29 May 2008

London, UK, 29 May 2008 – Lipoxen PLC (AIM:LPX) a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, announces today positive results from a Phase I trial of SuliXen^®, its long-acting insulin candidate for Type 1 and Type 2 diabetes. The data have shown the candidate to be safe and well tolerated with no adverse events attributed to the product being reported in the treated patients.

The Phase I study, which is taking place at the Federal State Center of Endocrinology in Moscow, Russia, involves 12 healthy volunteers, each receiving 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 first data set reported here has been extracted from the first cohort of four patients with the next cohort to include eight patients.

The trial also provided initial data on the product candidate’s pharmacodynamics. In cohort 1 (which involved 12 euglycemic hyperinsulinemic clamps), those who received SuliXen dosing of 0.1 IU\kg or 0.3 IU\kg showed a clear pharmacodynamic response, as demonstrated by the increased glucose infusion rate (GIR), while insulin glargine at 0.2IU/kg failed to increase the GIR in some patients. The patients’ individual pharmacodynamic responses both for SuliXen 0.1 IU\kg and 0.3 IU\Kg doses were greater than for 0.2 IU\kg of insulin glargine. These data demonstrate that Lipoxen is progressing towards the goal of having a superior formulation to Lantus, the world’s most-prescribed insulin which generated sales of over $3 billion in 2007¹.

SuliXen, a long-acting insulin, is formulated using Lipoxen’s proprietary PolyXen® technology. This platform technology, which has the potential to be applied to hundreds of drugs, 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. Key benefits of PolyXen^® for protein drug delivery include reduced frequency and amount of dosage, prolonged pharmacological action and reduced immunogenicity and antigenicity.

M. Scott Maguire, CEO of Lipoxen, said:

“The data announced today demonstrate that, with SuliXen, we are on our way to achieving our goal of developing a more efficacious insulin formulation with a reduced dosing regime, with which we could become a recognised competitor in the $12 billion insulin market. With the World Health Organization expecting there to be over 300 million diabetes sufferers worldwide by 2025, there is a clear market need for alternative insulin formulations such as SuliXen.”

 “These data build upon the recently announced positive Phase I results from our long-acting erythropoietin (EPO) candidate, ErepoXen^®, which demonstrated that the therapy could be suitable for once-monthly administration and competing in the $9 billion EPO market.”

 “With these data further confirming the validity of the Company’s technology, this is a very exciting time for Lipoxen and we look forward to further positive results from our high value differentiated biologicals in the clinic”.

 1. Sanofi-aventis Annual Report 2007