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Lipoxen PLC (XEN)

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Monday 01 March, 2010

Lipoxen PLC

ErepoXen Phase II Trial Comme

RNS Number : 8087H
Lipoxen PLC
01 March 2010
 



For immediate release

1 March 2010

 

 

 

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:

 

Lipoxen plc

+44 (0)20 7389 5015

M. Scott Maguire, Chief Executive Officer




Singer Capital Markets (nominated adviser)

+44 (0)20 3205 7500

Jeff Keating, Claes Spång




Noble & Company

+44 (0)20 7763 2200

James Bromhead, Sam Reynolds   




Buchanan Communications

+44 (0)20 7466 5000

Lisa Baderoon, Catherine Breen


 

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 £2.9 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
 
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