Interim Phase I Results - Long-Acting EPO

 

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 
 
 
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| Lipoxen PLC                       |                                    | 
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| M. Scott Maguire, Chief Executive | [phone]                | 
| Officer                           |                                    | 
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|                                   |                                    | 
+-----------------------------------+------------------------------------+ 
| Teathers                          | [phone]                | 
+-----------------------------------+------------------------------------+ 
| Claes Spång                       |                                    | 
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|                                   |                                    | 
+-----------------------------------+------------------------------------+ 
| Citigate Dewe Rogerson            | [phone]                | 
+-----------------------------------+------------------------------------+ 
| 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 
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 
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performance or achievements expressed or implied by such forward-looking 
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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 
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factors, readers are cautioned not to rely on any forward-looking statement. 
 
 
 
 
 
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