LPX Lipoxen

 

TIDMLPX 
 
RNS Number : 8087H 
Lipoxen PLC 
01 March 2010 
 

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| For immediate release           |                    1 March 2010 | 
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                                  Lipoxen plc 
                          ('Lipoxen' or 'the Company') 
 
                       ErepoXen Phase II Trial Commences 
 
Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the 
development of high-value differentiated biologicals, vaccines and siRNA 
delivery, is pleased to announce that its partner, the Serum Institute of India 
("Serum Institute"), has now commenced first dosing of patients for Lipoxen's 
expanded Phase II trial of ErepoXen  in India. 
 
Lipoxen's ErepoXen product candidate is an enhanced polysialylated form of 
erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood 
cell production and prevent anaemia caused by chronic renal (kidney) failure or 
chemotherapy. ErepoXen uses Lipoxen's PolyXen  platform technology to attach 
polysialic acid (PSA), a polymer of sialic acid (a biodegradable sugar that is 
found naturally in the human body) to protein drugs. 
 
The trial is an open label Phase II ICH-GCP compliant trial involving 30 
patients with anaemia, across 6 trial centres in India. The primary endpoints of 
the trial are improved red blood cell count, reticulocytes, hemoglobin and 
hematocrit. Secondary endpoints will measure safety, a reduction in the 
frequency of injections versus current EPOs, and immunogenicity. Clinigene 
International Ltd, a Biocon group company based in Bangalore is the contract 
research organization running the trial.  Results on this trial are scheduled to 
be reported early Q3 this year. 
 
As reported in early February, the Serum Institute agreed to accelerate the 
product candidate towards marketability by expanding the planned trial into a 
fully integrated Phase II US FDA compliant trial and to meet the additional 
costs associated. 
 
Commenting on the Phase II trial, M. Scott Maguire, CEO of Lipoxen, said: "The 
commencement of our Phase II ErepoXen trial with the Serum Institute under 
European regulations in India is a very exciting step forward. EPO is a 
currently $9B drug and is injected 1-3 times per week.  Our EPO is designed to 
last for one month so we are very excited about moving this potential 
blockbuster candidate into patient trials having had a successful Phase I trial. 
 Not only will the trial measure the potential benefits of our enhanced EPO 
product candidate, but positive results will assist Lipoxen to execute further 
licensing deals that combine our versatile PolyXen  platform technology with 
existing protein drugs." 
 
                                    - Ends - 
 
For further information please contact: 
 
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| Lipoxen plc                              |     +44 (0)20 7389 | 
|                                          |               5015 | 
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| M. Scott Maguire, Chief Executive        |                    | 
| Officer                                  |                    | 
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|                                          |                    | 
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| Singer Capital Markets (nominated        |     +44 (0)20 3205 | 
| adviser)                                 |               7500 | 
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| Jeff Keating, Claes Spång                |                    | 
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|                                          |                    | 
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| Noble & Company                          |     +44 (0)20 7763 | 
|                                          |               2200 | 
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| James Bromhead, Sam Reynolds             |                    | 
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|                                          |                    | 
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| Buchanan Communications                  |     +44 (0)20 7466 | 
|                                          |               5000 | 
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| Lisa Baderoon, Catherine Breen           |                    | 
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Notes for Editors 
 
About Lipoxen 
Lipoxen plc is a biopharmaceutical company focused on the development of new and 
improved biologic drugs and vaccines.  Lipoxen has three proprietary patented 
technology platforms: 
 
1) PolyXen - for extending the efficacy and half life of biologic drugs 
2) ImuXen - for creating new vaccines and improving existing vaccines 
3) SiRNAblate - for the delivery of siRNA 
 
Lipoxen's technology is designed to improve the efficacy, safety, stability, 
biological half-life and immunologic characteristics of its products. 
 
Lipoxen has multiple drug and vaccine programmes in development.  Two products 
are in clinical development, SuliXen, a long acting insulin and ErepoXen, a 
long-acting erythropoietin (EPO). Lipoxen's preclinical pipeline includes 
vaccines against HIV, influenza and malaria and an exclusive license deal with 
Baxter Healthcare for Factor VIII. 
 
The Company has a low-risk business model and out-licenses its proprietary 
technologies to biopharmaceutical companies that have strong manufacturing and 
marketing capabilities.  Lipoxen currently has commercial agreements with some 
of the world's leading biotechnology and pharmaceutical companies including 
Baxter, Schering-Plough, the Serum Institute of India Limited, Genentech, and 
Genzyme. Furthermore, Baxter, the Company's third largest shareholder, and 
management led the GBP2.9 million fundraising that the Company announced in May 
2009. 
 
Lipoxen, which was founded in 1997, now trades on the AIM Market of the London 
Stock Exchange under the ticker symbol LPX. More information can be found at the 
Company's website: www.lipoxen.com. 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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