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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
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Lipoxen | LSE:LPX | London | Ordinary Share | GB00B08NWV55 | ORD 0.5P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 7.875 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
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0 | 0 | N/A | 0 |
RNS Number:6713S Lipoxen PLC 21 April 2008 Lipoxen Announces Positive Phase I Results with its Long Acting EPO Product Candidate - ErepoXen(R) First positive human clinical data demonstrates the potential of Lipoxen's PolyXen(R) technology to enhance the delivery of a broad range of biotherapeutics London, UK, 21 April 2008 - Lipoxen PLC, (AIM:LPX) a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and oncology drugs, announces today positive initial results from the first Phase I trial of ErepoXen(R), a long-acting EPO. This trial, which was conducted by Lipoxen's partner, Serum Institute of India, showed that the product candidate was well tolerated and has the potential to be administered on a once monthly basis. 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. ErepoXen(R), which is being developed to treat anaemia in patients receiving renal dialysis, has been formulated using Lipoxen's proprietary PolyXen(R) delivery technology which is also being used in the development of a series of other product candidates The Phase I trial, which was carried out at the Veeda Clinical Research Pvt in India, was a randomised double-blind placebo-controlled single dose study. The trial was designed to assess the safety, tolerability and efficacy of EPO 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 trial recruited 32 healthy adult males, 24 of whom received ErepoXen(R) while eight received placebo, via subcutaneous injection. The patients who received ErepoXen(R) were assigned to two groups one of which received 0.5 micrograms/kg (body weight) and the other received 1.5 microgram/kg. The initial results from the Phase I study show that ErepoXen(R) is safe and well tolerated with no adverse events attributed to the product being experienced in any of the treated patients. The trial also provided initial data on the product candidate's pharmacokinetics. In the patients receiving the higher dose of ErepoXen(R) there was a clear reticulocyte (immature red blood cells) response which lasted for two weeks. In addition, there was a sustained rise in haemoglobin levels which lasted for 28 days in these patients. Commenting on the results, Dr. Mikhail Ashraf, Consultant Nephrologist and Senior Medical Tutor, Swansea University, said, "These results from early cohorts are very encouraging. The 28 day sustained haemoglobin rise and the lasting reticulocyte response indicate that this preparation could be suitable for once monthly administration. With most current erythropoietin therapies administered between once and three times a week, ErepoXen(R) has the potential to fulfill a large unmet medical need in anaemia management and I look forward to following its development." M. Scott Maguire, CEO of Lipoxen, said: "We are extremely pleased that the initial results from the first Phase I trial with ErepoXen(R) have been so positive. The study has shown the product candidate to be safe and well tolerated, and also demonstrates that this long-acting erythropoietin, which has been formulated using our proprietary PolyXen(R) technology, has the potential to be administered on a once a month basis. This could be a key competitive advantage for ErepoXen(R) as there is a clear demand from patients for improved forms of EPO, which have, in particular, less frequent dosing and more patient convenience. In 2007, the overall global market for EPO was worth $9 billion. Today's announcement is a major milestone for Lipoxen's business as it is the first human data showing that we can use our PolyXen(R) technology to improve the delivery of biological drugs, a growing and highly profitable segment of the overall pharmaceutical market. We are currently conducting a Phase I study with our long-acting insulin product SuliXen and I am confident that this study will also produce a positive outcome. With two high-value differentiated biologicals under development and a portfolio of delivery technologies which is attracting interest from a growing list of potential partners, I believe that Lipoxen is well positioned to generate significant shareholder value over the remainder of 2008." - ENDS - Enquiries Lipoxen PLC M. Scott Maguire, Chief Executive Officer +44 (0)20 7691 3583 Landsbanki Securities +44 (0)20 7426 9000 Shaun Dobson / Claes Spang Citigate Dewe Rogerson +44 (0)20 7638 9571 David Dible / Heather Keohane Notes to Editors Further information on Lipoxen 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 human insulin and ErepoXen(R), 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. This information is provided by RNS The company news service from the London Stock Exchange END RESBXGDSDUBGGII
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