TIDMLPX
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
0.5ug/kg, 1ug/kg or 2 ug/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 Spang
Walbrook PR Ltd +44 (0)20 7933 8780
Bob Huxford (Media Enquiries) Mob: 07747 653 908
bob.huxford@walbrookpr.com
Paul Cornelius (Investor Enquiries) Mob: 07866 384 707
paul.cornelius@walbrookir.com
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 GBP2.9 million fundraising that
the Company announced in May 2009. This fundraising was followed up
by a GBP1.2 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:
www.lipoxen.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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