Positive Phase I Clinical Data

 

TIDMLPX 
 
RNS Number : 7351R 
Lipoxen PLC 
06 May 2009 
 
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| For immediate release                             |                                        6 May 2009 | 
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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). 
 
 
Highlights: 
      -    Data supports once monthly dosing (current EPO patients require up to 
three doses per week  at a cost 
 

          of 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 a 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), (a 
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: 
 
 
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| Lipoxen plc                                     |    [phone]  | 
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| M. Scott Maguire, Chief Executive Officer       |                         | 
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|                                                 |                         | 
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| Singer Capital Markets (nominated adviser)      |     [phone] | 
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| Jeff Keating / Claes Spång                      |                         | 
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|                                                 |                         | 
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| Noble & Company                                 |   [phone]  | 
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| John Llewellyn-Lloyd / Sam Reynolds             |                         | 
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|                                                 |                         | 
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| Buchanan Communications                         |     [phone] | 
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| Mary-Jane Elliott, Lisa Baderoon, Rebecca Skye  |                         | 
| Dietrich, 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 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: www.lipoxen.com. 
 
 
 
 
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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