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January 23 2003, Press release
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| FIT Biotech Plc acquired assets of Xenerate Ab and starts the development of novel gene technology based vascular devices |
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FIT Biotech Plc announced today that it starts a development of new biocompatible cardiovascular devices, applying its proprietary Gene Transport Unit (GTU®) technology. FIT Biotech acquired the intellectual property rights and other assets of Xenerate AB, a company combining medical devices and gene therapy. Together, FIT Biotech's knowledge in DNA plasmids and gene therapy, and Xenerate's background in cardiovascular device technology, will create a unique platform for the development of medical devices for the treatment of cardiovascular diseases.
Introduction:
Cardiovascular diseases remain the leading cause of death in developed countries. Reduced or disrupted blood flow to the affected tissues and organs may result in a variety of scenarios, including amputation or death through myocardial infarction. While some of these conditions can be treated through diet, exercise and a variety of oral therapies, extensive disease-related blood vessel damage requires more invasive therapies. Vascular bypass grafts and endovascular implants (stents and stent grafts) are used in patients whose blood vessels have become blocked or damaged, as a result of a disease or trauma.
FIT Biotech acquired the intellectual property rights and other assets of Xenerate AB, Uppsala Sweden (www.xenerate.com). These include several patent applications, trademarks (X-Stent, X-Graft, X-Endo, Xenerate) and results of preclinical development. The acquired technology constitutes a platform contributing to improved efficacy of cardiovascular implants and prosthetic vascular grafts, through the application of novel surface structures and concurrent gene therapy. FIT Biotech expects to apply its GTU® gene delivery vehicle, in combination with the Xenerate concept, to further add value to the acquired technology.
In view of the markets pertaining to the acquired Xenerate concept, coronary heart disease caused some 530.000 deaths in 1999 in the USA alone, and approximately 1.300.000 coronary stents were implanted and 600.000 coronary bypass operations were performed worldwide. In bypass surgery patient's own arteries or veins are harvested to create bypass grafts that channel blood flow around the diseased coronary arteries. In this market there is a great need for acceptable prosthetic alternatives, which are currently not available. Further needs for vascular grafts and devices arise e.g. from peripheral artery disease, strokes, and kidney disease, corresponding to a present usage of 120.000 peripheral stents and 350.000 grafts annually. In these areas, prosthetic vascular grafts are used, although the results, with currently available products on the market, are worse than with the use of body's own vessels e.g. vein graft. In all, the potential application areas of the Xenerate concept comprise an immense market opportunity for medical devices, worth more than USD 5 billion (Cardiovascular Device Handbook, J.P. Morgan, 2)
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| Xenerate's technology and IPR pipeline |
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Xenerate Stimulation Technology (XST) - Cardiovascular Implants with DNA plasmid. XST aims to create biocompatible surfaces on synthetic implants such as synthetic grafts and stent grafts. Implants based on the XST platform, have the potentially unique capacity of developing endothelial surfaces, with the help of genes that lead to production of growth factors that stimulate angiogenesis, i.e. generation of new blood vessels.
Xenerate Inhibition Technology (XIT) - Cardiovascular Stents with Gene Transfer. XIT is intended to improve the function of stents by aiming to prevent intimal hyperplasia, leading to restenosis. In contrast to the currently available drug-coated stents which may harm the protective endothelial cells, XIT expedites the body's healing process with less inflammation and faster endothelial cell recovery.
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| FIT Biotech's GTU® based Cardiovascular Devices product family |
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FIT Biotech aims to build up GTU® based product development pipeline containing vascular and endovascular grafts and stents:
GTU® X-GRAFT, GTU® X2-GRAFT (based on XST) - the objective is to develop improved synthetic grafts, i.e. vessels to bypass or replace damaged arteries, with long-term patency, initially for use in peripheral anatomical locations. Potentially, X-GRAFT will inhibit thrombus formation and occlusion by creating a native endothelialised surface on the synthetic graft's inner surface, as well as improving the capacity to resist bacterial infections. In the product names, the X2 brand is used to distinguish products that are coated with genes from those used with concurrent administration of a gene solution or gel.
GTU® X-STENT, GTU® X2-STENT (XIT) - stenting is a non-surgical treatment used coincident with balloon angioplasty to treat occlusive artery disease. Once angioplasty has widened a diseased artery, a stent is inserted. X-STENT is expected to resolve the problem of achieving long-term patency, by inhibiting restenosis, after stent implantation. By promoting the normal endothelial cell-mediated healing in the body, without excessive inflammation in the vessel wall, X-STENT is predicted to have a remarkable market opportunity in coronary, carotid and peripheral intervention.
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| The Company |
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FIT Biotech Plc is an innovative medical biotechnology company engaged in the development and commercialization of its proprietary Gene Transport Unit (GTU®) technology and GTU®'s product applications in DNA vaccination, and immuno- and gene therapies. The Company's other areas of expertise are artificial multiepitope immunogens, recombinant protein and antibody technologies, and GMP class process development for DNA based vaccines. In addition, the Company has developed and launched diagnostic products for the detection of natural rubber allergens. The Company was established in 1998 and is located in Tampere, Finland, with operations also in Tartu, Estonia, and in Bangkok, Thailand.
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| Further information |
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Pekka Sillanaukee, CEO & President
FIT Biotech Oyj Plc.
Tel. +358 3 3138 7000
Fax. +358 3 3138 7050
Mobile +358 40 833 1313
pekka.sillanaukee@fitbiotech.com
www.fitbiotech.com
www.xenerate.com
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