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Thursday 27 November, 2008

Lipoxen PLC

Agreement to Investigate Suli

RNS Number : 0142J
Lipoxen PLC
27 November 2008

Lipoxen PLC

('Lipoxen' or 'the Company') 

Lipoxen Signs Agreement with the Barbara Davis Center for Childhood Diabetes to Investigate SuliXen™ in Type I diabetes

London, UK, 27 November 2008 - Lipoxen PLC (AIM:LPX), a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and oncology drugs, announces today it has entered into a Materials Transfer Agreement (MTA) for SuliXen[TM] with the Barbara Davis Center for Childhood Diabetes. Under the terms of the Agreement Lipoxen will provide the Barbara Davis Center with SuliXen[TM], its unique long-acting formulation of insulin, for initial preclinical studies in models of diabetes. The evaluation is designed to explore whether SuliXen[TM] has the potential to reverse, limit or prevent the development of type I diabetes. A similar evaluation will be conducted with Lantus[R] (sanofi-aventis), the world's largest selling insulin product which generated sales of over $3 billion in 2007. The Barbara Davis Center for Childhood Diabetes is one of the largest diabetes programmes specialising in type-I diabetes research and care (both children and adults) in the world and is part of the University of Colorado Denver School of Medicine.

Lipoxen and the Barbara Davis Center will evaluate SuliXen[TM] to see how the unique properties of this long-acting insulin formulation may deliver benefits for patients with type-I diabetes. Type-I diabetes is an autoimmune disease in which the immune system destroys the insulin producing beta-cells of the pancreas. The insulin in beta-cells is thought to be one of the major targets that identifies these cells for destruction by the immune system. Human clinical studies have shown already that SuliXen[TM] very effectively suppresses endogenous insulin production (insulin produced by the patient). It is expected that, by suppressing endogenous insulin production, SuliXen[TM] may avert the autoimmune destruction of the beta-cells, which will no longer be 'flagged' for destruction by the insulin that they produce. Furthermore, SuliXen itself has been found to be less able than natural insulin to fuel immune reactions, meaning that, in a second possible mode of action, it may interfere with the initiation and propagation of the T-cell mediated autoimmune processes that destroy beta cells. This evaluation of Sulixen[TM] will take place in animal models of type-I diabetes.

The agreement with Babara Davis Center highlights further the interest in Lipoxen's unique PolyXen[TM] protein drug delivery platform. The platform is currently being evaluated by a number of the world's leading biopharmaceutical companies as a way of improving the delivery of products that are currently on the market or in development. 

The principal investigator in the study is Dr. Edwin Liu, section of Gastroenterology, Hepatology and Nutrition, The Children's Hospital, AuroraColo., and Assistant Professor of Pediatrics, UC Denver School of Medicine. Dr Liu's primary research interest is T-cell immunobiology in diabetes and he has already been involved in extensive research in the area.

In addition, Lipoxen is developing its own product pipline based on its PolyXen[TM] technology and has already reported positive initial Phase I data with SuliXen[TM] and its long-acting formulation of EPO, ErepoXen[R] - further emphsising the significant potential of its unique delivery technology. The final results from both of these Phase-I studies, which are expected to confirm the efficacy, dosing benefits and safety of these two products, are due to be released in the next several months. 

M. Scott Maguire, CEO of Lipoxen, said:

'We are delighted to have the opportunity to be working with the Babara Davis Center for Childhood Diabetes, a world leader in diabetes care, to evaluate the potential benefits that SuliXen[TM] could bring to patients with type-I diabetes. Over the next few months the Center will use its research expertise to assess whether SuliXen[TM] could play an important role in the immunologic prevention of diabetes. 

This agreement is in line with our strategy of maximising the benefits that we could bring to the overall diabetes population, a $17 billion market, with SuliXen[TM], our unique long acting insulin product. Our Phase I clinical studies to-date have already shown that we are well on our way to have a product which will offer important important commercial advantages and if we could show that it could also play an important role in helping delay or prevent the onset of type-I diabetes, this would be a further very positive development for both the diabetes community and Lipoxen.'

George Eisenbarth, MD, Director of the Barbara Davis Center for Childhood Diabetes, said:

'At the Center we continuously strive to access new technologies that may hold future promise for patients with diabetes. We are very excited to be entering into this collaboration with Lipoxen to explore how the properties of SuliXen[TM], a novel acting insulin, may deliver benefits to these patients through reversing, limiting or even preventing the development of type-I diabetes. 

The care for diabetes is changing dramatically and, with continued research, we believe the disease, and many of its complications, can be effectively treated, delayed or prevented for the majority of individuals developing diabetes today. We look forward to the positive results we believe this collaboration will reveal and the potential benefits that they may offer to all patients with diabetes.'

- ENDS -


Lipoxen PLC

M. Scott Maguire, Chief Executive Officer

+44 (0)20 7691 3583 

Teathers (nominated adviser)

Claes Spång 

+44 (0)20 7426 9000

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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