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Lipoxen PLC (XEN)

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Wednesday 06 May, 2009

Lipoxen PLC

Positive Phase I Clinical Dat

RNS Number : 7351R
Lipoxen PLC
06 May 2009

For immediate release
6 May 2009

Lipoxen plc

('Lipoxen' or 'the Company')

Positive Phase I Clinical Trial Results for ErepoXen®

~ A Novel Long-Acting EPO Product ~

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 today that it has received positive Phase I clinical trial results for both efficacy and toxicity from the Company's long-acting erythropoietin (EPO) candidate, ErepoXen®.  ErepoXen® is being developed as a long-acting form of EPO, a product with annual sales of US$9bn, for the treatment of anaemia in cancer and renal disease patients. The study was conducted and funded by Lipoxen's partner and major shareholder, Serum Institute of India Limited (SIIL). 


      -    Data supports once monthly dosing (current EPO patients require up to three doses per week  at a cost
approximately $9k per patient per year in the UK)
      -    Significant red blood cell response which lasted between 14 and 20 days after dosing
      -    Sustained rise in haemoglobin levels for 28 days after dosing
      -    Drug well tolerated with no safety issues
      -    Phase II studies will commence in this quarter in India and a Phase I/II study in Canada in H2 09
      -    Product scheduled for market launch in Russia in 2011
      -    Discussions continuing with potential licensing partners 

This large Phase I trial was a randomised double-blind placebo-controlled single dose study and comprised 64 healthy adult males, 48 of whom received ErepoXen® while 16 received placebo. The subjects who received ErepoXen® were assigned to four dose cohorts: 0.5, 1.5, 3.0 and 4.5 micrograms/kg respectively. The trial was designed to assess the safety, pharmacokinetics and pharmacodynamics of ErepoXen®the polysialylated EPO, formulated using Lipoxen's proprietary PolyXen® technology. This technology is based on polysialic acid (PSA), (polymer occurring naturally in humans) which extends a protein's active life, is biodegradable, non-immunogenic and non-toxic, and which is also therefore expected to avoid the toxicity attributed to polyethylene glycol in PEGylated protein drug candidates. 

The pharmacodynamic data showed that ErepoXen® exerts a dose-dependent increase in reticulocyte (immature red blood cell) count. This increase was particularly prominent in the subjects receiving the two higher doses of ErepoXen®, with maximum reticulocyte count reached seven days after dosing. These subject's reticulocyte counts then took between 14 and 20 days to return to baseline values, suggesting that ErepoXen® could exert a long-acting effect on erythropoiesis (red blood cell production). This effect is comparable to that observed with CERA (Continuous Erythropoietin Receptor Activator), a Roche product, and is significantly longer than that observed with other shorter acting currently marketed EPOs.  Subjects receiving ErepoXen® also saw an increase in haemoglobin levels when compared to baseline and these effects lasted up to 28 days after dosing

Phase II studies with ErepoXen® are planned to commence in India this quarter and market launch is expected in Russia in 2011. A Phase I/II study in Canada will be conducted according to FDA guidelines and will also commence before the end of 2009. These clinical studies will be funded by SIIL, India's largest biotech company.

Commenting on this announcement, M. Scott Maguire, CEO of Lipoxen, said: 'We are very excited about this new clinical data which indicates that Lipoxen's ErepoXen® candidate has the potential to provide an improved and more convenient dosing regime for patients plus significant economic benefits for healthcare providers compared to current EPO products. The revenues for current EPOs (injected once to three times per week) totalled $9 billion in 2007 and thus we look forward to moving this product, which is funded by our partner, the Serum Institute of India, forward and into Phase II clinical trials next month. We have already begun discussions with potential commercial partners around this candidate and expect to sign a significant licensing deal in due course. Today's new data, together with the exciting flu vaccine data released last week, shows that Lipoxen's technologies are addressing pressing healthcare needs.' 

Adding to this announcement, the Phase I study's Principal investigator, Dr. Mikhail Ashraf*, Consultant Nephrologist and Senior Medical Tutor, Swansea University, said:  'I am pleased that the results we have announced today continue to confirm the excellent safety profile of polysialylated EPO. The overall data, particularly the mean reticulocyte and haemoglobin response, suggests that this novel EPO preparation would be suitable for once monthly administration.'

*Dr. Ashraf, an advisor to major multinational companies, has participated extensively in clinical trials of EPOs. He is an expert in anaemia management and has a special interest in erythropoiesis, having conducted phase-II and phase-III clinical trials for short and long acting ESAs.

- Ends -

For further information please contact:

Lipoxen plc

+44 (0)20 7691 3583 

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 

John Llewellyn-Lloyd / Sam Reynolds  

Buchanan Communications

+44 (0)20 7466 5000

Mary-Jane Elliott, Lisa Baderoon, Rebecca Skye Dietrich, 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 product candidates.  

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 candidates for Factor XIII and vaccines against HIV, influenza and malaria.  

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, Sanofi-Aventis, the Serum Institute of India Limited, Genentech, Amgen and Genzyme.  

Lipoxen plc, which was formed as a spin-out from The School of Pharmacy at the University of London, trades on the Alternative Investment Market (AIM) of the London Stock Exchange under the ticker symbol LPX. More information can be found at the Company's website:

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