Interim Phase I Results - Long-Acting EPO
January 15 2009 - 2:00AM
UK Regulatory
TIDMLPX
RNS Number : 6632L
Lipoxen PLC
15 January 2009
Encouraging Interim Phase I results from Lipoxen's Long-Acting EPO Product
Candidate - ErepoXen[R]
Data highlight candidates' excellent safety profile and ability to
exert long-acting effect on erythropoiesis
London, UK, 15th January 2009 - Lipoxen PLC, (AIM:LPX) a bio-pharmaceutical
company specialising in the development of high-value differentiated
biologicals, vaccines and oncology drugs, announces today encouraging interim
Phase I trial results on the company's long-acting erythropoietin (EPO)
candidate, ErepoXen[R]. These results show the product candidate to have an
excellent safety profile and suggest that it may be suitable for administration
on a once-monthly basis. ErepoXen[R] is being developed to treat anaemia in
patients receiving renal dialysis.
The Phase I trial is s a randomised double-blind placebo-controlled single dose
study and was designed to assess the safety, pharmacokinetics and
pharmacodynamics of polysialylated EPO, ErepoXen[R], formulated using Lipoxen's
proprietary PolyXen[R] technology. This technology is based on polysialic acid
(PSA), a naturally occurring polymer which extends a protein's active life, is
biodegradable, non-immunogenic and non-toxic, and which is also expected to
avoid the toxicity attributed to polyethylene glycol in PEGylated protein drug
candidates.
The interim Phase I trial results announced today are based on 48 healthy adult
males, 36 of whom received ErepoXen[R] while 12 received placebo. The patients
who received ErepoXen[R] were assigned to three cohorts, the first receiving 0.5
micrograms/kg (body weight), the second 1.5 micrograms/kg and the third 3.0
micrograms/kg. A fourth cohort of people has now been recruited to the study and
they will receive a dose of 4.5 micrograms/kg. The results from the complete
Phase I study are expected to be released in the coming months. Based on the
encouraging results seen to-date a Phase II is planned to commence in India in
the middle of 2009. This study will be funded by Lipoxen's partner, Serum
Institute of India (SIIL).
The interim data on the product candidate's pharmacodynamics showed that
ErepoXen[R] exerts a dose dependent increase in reticulocyte (immature red blood
cell) count. This increase was particularly prominent in the patients receiving
the two higher doses of ErepoXen[R], with maximum count reached seven days after
dosing. These patients reticulocyte count then took between 14 and 20 days to
return to baseline values, suggesting that the ErepoXen[R] could exert a
long-acting effect on erythropoiesis. This effect is comparable to that observed
with Hematide (Affymax) or CERA (Continuous Erythropoietin Receptor Activator)
(Roche), and is significantly longer than that observed with shorter acting
Erythropoiesis Stimulating Agents (ESAs). Patients receiving ErepoXen[R] also
saw an increase in haemoglobin levels when compared to baseline. Hb levels in
the cohort receiving 1.5 microgram/kg show an early rise in Day 7 and show
maximal response at Day 28 of the study.
Current EPO therapies are generally administered between once and three times a
week and hence ErepoXen[R] could provide a much improved dosing regime for
patients.
M. Scott Maguire, CEO of Lipoxen, said:
'We are very excited about these results and look forward to moving this
candidate to the next phase in its development in the next few months. In 2007,
the overall global market for EPO was worth $9 billion and the potential for
this product to be administered on a less frequent basis than current EPO
products offers us a very exciting opportunity both scientifically and
commercially, is and one that we intend to fully investigate in order to bring a
more convenient product for both patient and physician to market."
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 response that lasted for over two weeks, suggests that
this novel EPO preparation could be suitable for use as a long-acting agent."
- ENDS -
Enquiries
+-----------------------------------+------------------------------------+
| Lipoxen PLC | |
+-----------------------------------+------------------------------------+
| M. Scott Maguire, Chief Executive | +44 (0)20 7691 3583 |
| Officer | |
+-----------------------------------+------------------------------------+
| | |
+-----------------------------------+------------------------------------+
| Teathers | +44 (0)20 7426 9000 |
+-----------------------------------+------------------------------------+
| Claes Sp�ng | |
+-----------------------------------+------------------------------------+
| | |
+-----------------------------------+------------------------------------+
| Citigate Dewe Rogerson | +44 (0)20 7638 9571 |
+-----------------------------------+------------------------------------+
| David Dible / Heather Keohane | |
+-----------------------------------+------------------------------------+
Notes to Editors
Lipoxen PLC (AIM:LPX) is a biopharmaceutical company specializing in the
development of high value differentiated biologicals, vaccines and oncology
drugs. Products currently under development include improved formulations of
important biologicals such as erythropoietin (EPO), G-CSF, insulin and
Interferon-alpha. Lipoxen has two products in clinical development SuliXen, a
long acting insulin and long-acting EPO. These novel products, which are based
on Lipoxen's proprietary PolyXen[R] technology, each address markets in excess
of US$1 billion.
Lipoxen's technology is designed to improve the stability, biological half-life
and immunologic characteristics of therapeutic proteins naturally. Lipoxen has
two further naturally-derived proprietary delivery technologies, ImuXen[R] and a
related liposomal technology for the formulation of cytotoxic oncology drugs,
which are being developed to enhance the efficacy and safety of various vaccines
such as a multivalent Hepatitis B-E and pneumococcal vaccines, as well as a
number of anti-cancer agents like paclitaxel. The Company's proprietary delivery
technologies are attracting significant interest and Lipoxen is currently
co-developing products with the Serum Institute of India Limited (one of the
world's leading vaccine companies, India's largest biotech company and a major
shareholder in Lipoxen) and has license agreements in place with Baxter
International and InterVet, a leading animal health company.
Lipoxen was admitted to trading on the AIM Market of the London Stock Exchange
in January 2006.
This announcement includes 'forward-looking statements' which include all
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This information is provided by RNS
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END
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