Positive Phase I Clinical Data
May 06 2009 - 1:00AM
UK Regulatory
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 | +44 (0)20 7691 3583 |
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| M. Scott Maguire, Chief Executive Officer | |
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| | |
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| Singer Capital Markets (nominated adviser) | +44 (0)20 3205 7500 |
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| Jeff Keating / Claes SpÄng | |
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| | |
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| Noble & Company | +44 (0) 20 7763 2200 |
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| John Llewellyn-Lloyd / Sam Reynolds | |
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| | |
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| Buchanan Communications | +44 (0)20 7466 5000 |
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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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