LPX Lipoxen

 

TIDMLPX 
 
RNS Number : 5191O 
Lipoxen PLC 
09 March 2009 
 

Lipoxen PLC 
("Lipoxen" or "the Company") 
 
 
Lipoxen announces positive final data from its completed Phase I study with its 
long-acting insulin candidate, SuliXen 
 
 
Data suggests SuliXen may have advantages over currently marketed insulin 
formulations 
 
 
London, UK, 9th March 2009 - 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 its completed 
Phase I trial of SuliXen , its long-acting insulin candidate for Type 1 and Type 
2 diabetes. The data have shown SuliXen to be safe and well tolerated with no 
adverse events attributed to the product candidate being reported in the treated 
volunteers. 
 
 
The Phase I cross-over study, which took place at the Federal State Center of 
Endocrinology in Moscow, Russia, involved 12 healthy volunteers, each receiving 
two doses of SuliXen (0.1IU/kg and 0.3IU/kg) as well as one dose of insulin 
glargine (Lantus, Sanofi-Aventis) dosed at 0.2IU/kg. This dosing regime was 
designed to allow a comparison with this commercially successful long-acting, 
insulin analogue. The data set announced today covers all of the treatments 
received by the 12 healthy volunteers taking part in the study. 
 
 
The study showed that both Sulixen, at both dosing levels, and insulin glargine, 
were well tolerated with no adverse events being observed during the Phase I 
trial. 
 
 
The trial also provided data on SuliXen's pharmacodynamics. In the study (which 
involved 36 euglycemic hyperinsulinemic clamps), those who received SuliXen 
dosing of 0.1 IUkg or 0.3 IUkg and insulin glargine dosed at 0.2IU/kg showed a 
clear pharmacodynamic response, as demonstrated by the increased glucose 
infusion rate (GIR). Importantly, the SuliXen treated patients showed no 
significant peaks in GIR within the observation period of the study suggesting a 
peak-less profile for Sulixen. 
 
 
The trial also showed that SuliXen both at 0.1 IUkg or 0.3 IUkg was more 
potent than Lantus at 0,2 IUkg. SuliXen has favorable pharmacokinetic profile, 
reaching maximum blood concentrations within 3 hours after subcutaneous 
injection and remaining in circulation up to 20-30 hours, depending from the 
dose injected. This was confirmed using an insulin immunoassay to measure 
insulin serum levels. 
 
 
These data demonstrate that with SuliXen, Lipoxen is well placed to achieve is 
goal of developing a  superior formulation to Lantus, the world's 
most-prescribed insulin which generated sales of $2.45  billion  in 20081. 
 
 
SuliXen, a long-acting insulin, is formulated using Lipoxen's proprietary 
PolyXen  technology. This  platform delivery technology, which has the potential 
to be applied to hundreds of biotherapeutics, both marketed and under 
development, is based on polysialic acid (PSA). PSA is 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 SuliXen data announced today shows that we are well on our way to 
developing a safe and novel insulin formulation that may well be more 
efficacious and provide a reduced dosing regime to currently marketed insulin 
products. This would make SuliXen an important new entrant into the $13 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 improved long acting insulin formulations such as SuliXen. I look forward to 
updating you on Phase II results as well as about novel applications of SuliXen 
in the field of reversal and/or prevention of Type I diabetes expecting through 
the research with the world renowned Barbara Davis Center for Childhood 
Diabetes later this year. " 
 
 
1. Sanofi-aventis Annual Results Presentation 2008 
 
 
 
 
Ends 
 
 
Enquiries 
 
 
+-----------------------------------+--------------------------------------+ 
| Lipoxen PLC                       |                                      | 
+-----------------------------------+--------------------------------------+ 
| M. Scott Maguire, Chief Executive | +44 (0)20 7691 3583                  | 
| Officer                           |                                      | 
+-----------------------------------+--------------------------------------+ 
|                                   |                                      | 
+-----------------------------------+--------------------------------------+ 
| Teathers (nominated adviser)      |                                      | 
+-----------------------------------+--------------------------------------+ 
| Claes Spång                       | +44 (0)20 7426 9000                  | 
+-----------------------------------+--------------------------------------+ 
|                                   |                                      | 
+-----------------------------------+--------------------------------------+ 
| Citigate Dewe Rogerson            | +44 (0)20 7638 9571                  | 
+-----------------------------------+--------------------------------------+ 
| David Dible / Heather Keohane     |                                      | 
+-----------------------------------+--------------------------------------+ 
 
 
Notes to Editors 
Lipoxen PLC (AIM:LPX) is a biopharmaceutical company specializing in the 
development of high value differentiated biologicals, vaccines and oncology 
drugs. Products currently under development include improved formulations of 
important biologicals such as erythropoietin (EPO), G-CSF, insulin and 
Interferon-alpha. Lipoxen has two products in clinical development SuliXen, a 
long acting insulin and long-acting EPO. These novel products, which are based 
on Lipoxen's proprietary PolyXen  technology, each address markets in excess of 
US$1 billion. 
 
 
Lipoxen's technology is designed to improve the stability, biological half-life 
and immunologic characteristics of therapeutic proteins naturally. Lipoxen has 
two further naturally-derived proprietary delivery technologies, ImuXen  and a 
related liposomal technology for the formulation of cytotoxic oncology drugs, 
which are being developed to enhance the efficacy and safety of various vaccines 
such as a multivalent Hepatitis B-E and pneumococcal vaccines, as well as a 
number of anti-cancer agents like paclitaxel. The Company's proprietary delivery 
technologies are attracting significant interest and Lipoxen is currently 
co-developing products with the Serum Institute of India Limited (one of the 
world's leading vaccine companies, India's largest biotech company and a major 
shareholder in Lipoxen) and has license agreements in place with Baxter 
International and InterVet, a leading animal health company. 
 
 
Lipoxen was admitted to trading on the AIM Market of the London Stock Exchange 
in January 2006. 
 
 
This announcement includes 'forward-looking statements' which include all 
statements other than statements of historical facts, including, without 
limitation, those regarding the Company's financial position, business strategy, 
plans and objectives of management for future operations (including development 
plans and objectives relating to the Company's products and services), and any 
statements preceded by, followed by or that include forward-looking terminology 
such as the words 'targets', 'believes', 'estimates', 'expects', 'aims', 
'intends', 'will', 'can', 'may', 'anticipates', 'would', 'should', 'could' or 
similar expressions or the negative thereof. Such forward-looking statements 
involve known and unknown risks, uncertainties and other important factors 
beyond the Company's control that could cause the actual results, performance or 
achievements of the Company to be materially different from future results, 
performance or achievements expressed or implied by such forward-looking 
statements. Such forward-looking statements are based on numerous assumptions 
regarding the Company's present and future business strategies and the 
environment in which the Company will operate in the future. Among the important 
factors that could cause the Company's actual results, performance or 
achievements to differ materially from those in forward-looking statements 
include those relating to The Company's funding requirements, regulatory 
approvals, clinical trials, reliance on third parties, intellectual property, 
key personnel and other factors. These forward-looking statements speak only as 
at the date of this announcement. The Company expressly disclaims any obligation 
or undertaking to disseminate any updates or revisions to any forward-looking 
statements contained in this announcement to reflect any change in the Company's 
expectations with regard thereto or any change in events, conditions or 
circumstances on which any such statements are based. As a result of these 
factors, readers are cautioned not to rely on any forward-looking statement. 
 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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