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Lipoxen PLC (XEN)

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Thursday 16 December, 2010

Lipoxen PLC

Positive Phase II Clinical Da

RNS Number : 0539Y
Lipoxen PLC
16 December 2010

16th December 2010

Lipoxen plc

('Lipoxen' or the 'Company')


Positive Phase II Clinical Data


Lipoxen (AIM: LPX.L), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, announces that it has received positive Phase II clinical trial results for both efficacy and toxicity from the Company's long-acting erythropoietin (EPO) candidate ErepoXen. EPO is a glycoprotein hormone secreted by the kidneys that controls red blood cell production. 


ErepoXen is being developed as a long acting form of EPO for the treatment of anaemia in renal disease patients. ErepoXen uses Lipoxen's proprietary PolyXen drug delivery technology which improves the efficacy, stability and half life of protein drugs and reduces risk of toxicity.


Chronic kidney disease (CKD) is highly prevalent, with around 2.455 million people worldwide receiving renal replacement therapy at the end of 2009  - nearly 1.895 million on dialysis and just over 560,000 with a functioning renal transplant*. The number of people with CKD at the end of 2009 was 6 - 7% higher than at the end of 2008* and it has been forecast that this prevalence will continue to increase.


The Phase IIa trials, which consisted of 30 subjects, were carried out by the Serum Institute of India Ltd, India's largest biotech company. This was a multi-centre, randomised, open-label single, subcutaneous dose study of polysialylated erythropoietin to assess safety, pharmacodynamics and pharmacokinetics in chronic kidney disease patients not on dialysis.


Thirty subjects were enrolled into the study in three cohorts of ten subjects each. The subjects were either male between the ages of 18 or 70 or post-menopausal females under 70 years of age. The subjects were randomised to receive subcutaneous doses of either 0.5µg/kg, 1µg/kg or 2 µg/kg of polysialylated erythropoietin in the anterior femoral skin.


Dr Ashraf Mikhail, MB.Bch, MSC, MD, FRCP, MBA, Consultant Nephrologist at the Morriston Hospital and Senior Clinical Tutor at Swansea University has reviewed  the study findings and has commented upon them as follows:


"The study confirms the findings of phase I trial. Polysialylated EPO is effective in increasing the reticulocyte count and thereby stimulating erythropoiesis in patients with Chronic Kidney Disease in a dose dependent manner. The rise in reticulocyte count is maintained for up to 28 days after a single injection. This finding suggests the drug may be effective when administered once monthly to patients with chronic kidney disease, thereby achieving maximal compliance and excellent outcome results". The results of the trial showed no adverse events, that the drug was well-tolerated and safe at all dose levels administered.


Lipoxen and The Serum Institute of India, as development partners in the project,  will now consider the optimum development path for the commercialisation of this exitcing product candidate;  this will include entering Phase II(b) trial in India as well as the possible out-licencing of the candidate to a commercial collaborator.



Commenting on the appointment, M. Scott Maguire, Chief Executive Officer of Lipoxen, said:


"I am absolutely delighted that this trial has delivered such excellent results and shown the potential for our PSA-EPO candidate to be a once-a month single dose therapy for renal disease patients.  The Lipoxen Board will be working closely with our colleagues at Serum Institute to accelerate the commercialisation of this candidate.  This is very exciting news indeed for Lipoxen and further underscores the viability of the PolyXen platform as a likely leading delivery methodology for a new wave of long-acting biosuperior biologic drug candidates."


* Fresenius Medical Care Annual Report 2009.


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




Walbrook PR Ltd

+44 (0)20 7933 8780

Bob Huxford (Media Enquiries)

Mob: 07747 653 908


Paul Cornelius (Investor Enquiries)

Mob: 07866 384 707



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 blood coagulation drugs.


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. This fundraising was followed up by a £1.2 million placing in April 2010 which was led by the Company's management team.


Lipoxen, which was founded in 1997, 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:

This information is provided by RNS
The company news service from the London Stock Exchange