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Lipoxen PLC (XEN)

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Thursday 15 January, 2009

Lipoxen PLC

Interim Phase I Results - Lon

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 monthsIn 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 Officer

+44 (0)20 7691 3583 



Teathers 

+44 (0)20 7426 9000

Claes Spång




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 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.




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