Biocompatibles International and British Biotech Announce Commencement of Clinical Trial Program for he Batimastat BiodivYsio-R- Stent.Business Editors OXFORD, United Kingdom & SURREY, United Kingdom--(BUSINESS WIRE)--Aug. 21, 2001--Biocompatibles and British Biotech British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] announced today the start of the program of patient trials of the Batimastat BiodivYsio(R) stent, a drug-coated device designed to reduce restenosis in patients who have undergone coronary angioplasty. A European multi-center trial, known as "BRILLIANT", is evaluating 150 patients for safety and efficacy which will be measured by angiographic restenosis at six months following deployment of the Batimastat BiodivYsio(R) stent. The first patients in this trial have been treated at the Cliniques Universitaires Saint Luc in Brussels by Professor Claude Hanet. The patient population will be closely matched and compared to a similar population that received the BiodivYsio(R) stent without batimastat in an earlier clinical trial, named "DISTINCT", completed by Biocompatibles in 1999. A further study will be undertaken, in parallel with BRILLIANT, to provide additional safety and efficacy data to support an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) submission to the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . Guy Leclerc, MD, of the Centre Hospitalier Universitaire de Montreal, Canada, the Principal Investigator for the pre-clinical studies, commented: "Biocompatibles has evaluated a large number of stents; batimastat demonstrates a dose-dependent response and early vessel healing with no local toxicity. This should be a safe and potentially effective treatment for patients." Under the terms of the collaboration between British Biotech and Biocompatibles, British Biotech will manufacture the batimastat to be loaded onto the BiodivYsio(R) stent and, as part of its funding of the program, will meet the costs of the European multi-center trial. Biocompatibles will manufacture and market the Batimastat BiodivYsio(R) stent and British Biotech will receive milestone payments and royalties on any future sales. Peter Stratford, Managing Director of Biocompatibles' Drug Delivery Division, commented: "We are very pleased to be able to start this study in the belief that batimastat, in combination with our proven PC Technology(TM), could offer patients a significant benefit." Dr Elliot Goldstein, Chief Executive Officer of British Biotech, said: "The Batimastat BiodiviYsio(R) stent gives us the opportunity to apply British Biotech's technology to a competitive new area. Building on the pre-clinical results, we expect this study to confirm the product's safety and determine its real clinical benefit for patients." This news release contains forward-looking statements that reflect the Companies' current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process. Notes to Editors Angioplasty and Restenosis Angioplasty is a minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an in which a balloon is inserted via a catheter into a blocked or occluded artery and expanded to reopen the artery. In a large proportion of angioplasty procedures a wire mesh (stent) is also placed in the artery to prevent it from closing again. Angioplasty and stenting have radically altered the treatment of heart disease, which previously involved major surgery with invasive by-pass procedures. Nevertheless, some patients receiving stents have overgrowth overgrowth Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced. of the lining of the artery around the stent, which leads to a re-blockage of the vessel (restenosis) in 20% of patients and in excess of 50% in some high-risk groups (e.g. diabetics). The fundamental biochemical and cellular processes that lead to restenosis have not been definitively established. It is, however, generally accepted that in addition to the vascular disease already present, the stretching of the vessel caused by ballooning results in an injury response in the local tissue. It is thought that the consequent inflammation, cell migration, smooth muscle cell replication and new endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium. Endothelial A layer of cells that lines the inside of certain body cavities, for example, blood vessels. cell growth, which are required for the normal healing process, may also lead to restenosis if the response is too strong. Stents coated with batimastat During the repair of damaged vessels, remodeling remodeling /re·mod·el·ing/ (re-mod´el-ing) reorganization or renovation of an old structure. bone remodeling of the extracellular matrix extracellular matrix (eksˈ·tr  ·selˑ·y occurs which involves matrix metalloproteinases
(MMP MMP Matrix Metalloproteinase (enzymes related to tissue healing/remodeling and cancer cell metastasis)MMP Mixed Member Proportional (New Zealand electoral system) MMP Multi-man Publishing ). Broad spectrum inhibitors of MMPs such as batimastat can inhibit the process of matrix degradation and subsequent cell migration that is implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in restenosis. Batimastat may also inhibit the collagen deposition and vessel remodelling that may play a role in restenosis. From preclinical evidence, the batimastat-coated stent may ameliorate the restenotic process and does allow the natural healing natural healing Alternative healing Alternative health Any healing technique that may be rooted in supernaturalist methods. See Absent healing, Acupuncture, Acupressure, Alexander technique, Applied kinesiology, Ayurvedic medicine, Bioenergetics, Cayce therapies, of the vessel to occur in a controlled manner. The BiodivYsio(R) stent The BiodivYsio(R) stent (without batimastat), utilizing Biocompatibles' PC Technology(TM) polymer coating, is commercially available in Europe; and in the U.S. where it is marketed by Biocompatibles' marketing partner, Abbott Laboratories, Inc. Biocompatibles International plc Biocompatibles is an international medical device company with three divisions, Cardiovascular, Drug Delivery and Eye Care, using a unique technology based on Phosphorylcholine ("PC"). PC Technology reduces the body's response to medical devices. PC is a chemical copy of part of the outer layer of a human cell membrane Cell membrane The membrane that surrounds the cytoplasm of a cell; it is also called the plasma membrane or, in a more general sense, a unit membrane. This is a very thin, semifluid, sheetlike structure made of four continuous monolayers of molecules. and is a synthetic polymer that can be coated onto medical devices or formed into products like contact lenses. Biocompatibles employs approximately 1,200 people around the world. The Company's cardiovascular distribution partner in the US is Abbott Laboratories and its distribution partner in Japan is Japan Lifeline. Biocompatibles' leading Drug Delivery programs are strategic partnerships with Abbott and British Biotech, and a program with the generic anti-inflammatory compound, Dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the . Further information, news releases and glossary are available on the Company's website at www.biocompatibles.co.uk. British Biotech plc British Biotech's strategy for creating shareholder value is to bring products to market for diseases with limited treatment options, by combining its expertise in drug development and product registration with the skills of other biotechnology and pharmaceutical companies. The Company comprises two distinct businesses: a Product Portfolio of drugs in active development; and an Antibiotic Program with the potential for multiple product opportunities. The four principal products in clinical development are: BB-10901, a tumor activated prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. for small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. ; E21R, a GM-CSF GM-CSF granulocyte-macrophage colony-stimulating factor. Granulocyte/macrophage colony stimulating factor (GM-CSF) A substance produced by cells of the immune system that stimulates the attack upon foreign cells. antagonist for acute myeloid myeloid /my·eloid/ (mi´e-loid) 1. medullary; pertaining to, derived from, or resembling bone marrow or the spinal cord. 2. having the appearance of myelocytes, but not derived from bone marrow. leukaemia; BB-10153, a novel thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts. thrombolytic 1. dissolving or splitting up a thrombus. 2. an agent that dissolves or splits up a thrombus. ; and the Batimastat BiodivYsio(R) stent for prevention of coronary restenosis. The lead compounds in its Antibiotic Program are peptide deformylase inhibitors in preclinical development for respiratory tract infections. With the commencement of the Batimastat BiodivYsio(R) stent, the Company has succeeded in entering three new products into patient studies over the last three months. British Biotech currently has collaborative product development Collaborative Product Development (Collaborative Product Design) (CPD) is a business strategy, work process and collection of software applications that facilitates different organizations to work together on the development of a product. agreements with Biocompatibles International plc, BresaGen Ltd, Devco Pharmaceuticals Ltd, ImmunoGen Inc., Schering-Plough Corporation, Serono SA, and Tanabe Seiyaku. Co. Ltd. Further information, news releases and glossary are available on the company's website at www.britishbiotech.com. |
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