FDA CLEARS THROMBOLYTIC DRUG FOR PHASE II CLINICAL TRIAL.British Biotech (LSE LSE - Language Sensitive Editor : BBG, Nasdaq: BBIOY), Oxford, England, has announced that the US Food and Drug Administration has given it the go-ahead to test the novel thrombolytic ("clot busting") agent, BB-10153, in heart attack patients. This follows British Biotech's submission of an Investigational New Drug (IND) application on February 19 this year to conduct a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of the drug in acute myocardial infarction acute myocardial infarction ( The Phase II trial will be conducted by the US-based Thrombolysis in Myocardial Infarction Thrombolysis In Myocardial Infarction (TIMI) is a large randomized controlled trial into myocardial infarction (heart attacks) and the use of thrombolysis. External links
1. to cause or produce disintegration of a compound, substance, or cell. 2. to undergo lysis. lyse or lyze v. To undergo or cause to undergo lysis. (dissolve) clots and restore blood flow in the coronary arteries of heart attack patients and to determine the safety of the treatment, especially with respect to bleeding. In this trial BB-10153 will be administered within six hours of the onset of clinical symptoms. Dr Eugene Braunwald, chairman of the TIMI Study Group said: "We are very interested in learning in this Phase II trial whether BB-10153 can successfully lyse clots and provide an acceptable safety profile in terms of bleeding risk." Dr Elliot Goldstein, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of British Biotech, said: "There is a clear need for safe and effective treatment of thrombotic diseases such as heart attack and stroke. BB-10153 has the potential to meet this need. We are very pleased that the TIMI Study Group will be carrying out the Phase II evaluation of BB-10153 and look forward to working closely with the group and to receiving the benefit of their outstanding experience in this area." The preclinical and Phase I testing of BB-10153 showed that the drug may overcome the risk of bleeding associated with currently-prescribed thrombolytic drugs. This is because BB-10153 is activated by thrombin, which is only produced at the site of a fresh blood clot. Therefore BB-10153, once activated, only dissolves recently-formed or still-forming clots. The Phase I trial of BB-10153 in healthy volunteers was completed in 1999 and showed the drug to be safe and well tolerated. British Biotech has subsequently been working closely with DSM 1. DSM - Data Structure Manager. An object-oriented language by J.E. Rumbaugh and M.E. Loomis of GE, similar to C++. It is used in implementation of CAD/CAE software. DSM is written in DSM and C and produces C as output. Biologics of Montreal, Canada, on the technology transfer and scale-up of manufacturing for the drug. DSM has now completed production of material to Good Manufacturing Practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. (GMP GMP (guanosine monophosphate): see guanine. ) standards for the Phase II trial. 1. The TIMI Study Group The Thrombolysis in Myocardial Infarction (TIMI) Study Group is an investigative team that has been at the forefront of clinical research in acute coronary syndromes over the past two decades. The TIMI Study Group organized in 1984 and led by Dr. Eugene Braunwald of Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. in Boston, Mass., is committed to advancing the knowledge and care of patients suffering from acute coronary syndromes by performing clinical research. 2. BB-10153 BB-10153 is an engineered form of human plasminogen, modified so that it is activated to plasmin plasmin /plas·min/ (plaz´min) an endopeptidase occurring in plasma as plasminogen, which is activated via cleavage by plasminogen activators; it solubilizes fibrin clots, degrades other coagulation-related proteins, and can be activated by thrombin, rather than by the body's natural plasminogen activators such as tpA. Thrombin-activatable plasminogen thus marks a new approach to thrombolysis in which thrombin, the key enzyme in blood clot formation, is utilised to initiate clot destruction. Conversion of natural plasminogen to plasmin (the active fibrinolytic fibrinolytic pertaining to or emanating from fibrinolysis. fibrinolytic agent substances that stimulate or inhibit fibrinolysis. fibrinolytic inhibitors include e-aminocaproic acid and antiplasmin-a1. enzyme) occurs on cleavage by a specific plasminogen activator. Enzymes involved in blood clot formation cannot activate natural plasminogen. Thus, the coagulation cascade and the fibrinolytic systems are functionally separate. However, thrombin-activatable plasminogen such as BB-10153 circumvents the physiological haemostatic mechanisms and selectively induces lysis of newly forming thrombi thrombi /throm·bi/ (throm´bi) plural of thrombus. . BB-10153's extended half-life (three to four hours) enables it to persist in the blood as an inactive pro-drug, activated only at fresh or forming blood clots by the thrombin that is localized there. Therefore, in addition to lysis of an existing clot, BB-10153 may prevent reocclusion and reduce the need for administration of a separate antithrombotic agent. In preclinical thrombolytic studies, the selective activation of BB-10153 at fresh clots resulted in highly localized plasmin activity. The preclinical data from these studies showed no evidence of systemic plasmin activity, no consumption of coagulation factors and no effect on bleeding time. BB-10153 may therefore cause fewer bleeding problems than current thrombolytics which, in contrast, do produce systemic plasmin at therapeutic doses. Furthermore, in the Phase I study of BB-10153, evidence of proof-of-concept fibrinolytic activity was obtained in ex vivo clot lysis assays and in vivo production of fibrin degradation products. British Biotech British Biotech specializes in the research, development and commercialization of new drugs to fight cancer and other diseases with limited treatment options. The company currently has four products in active clinical development: -- BB-10901: currently in Phase I/II in 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. . British Biotech was granted exclusive European and Japanese development and commercialization rights in May 2000 under an agreement with ImmunoGen Inc. (Boston, USA); -- E21R: currently in Phase II in acute myeloid leukaemia. British Biotech was granted exclusive worldwide development and commercialization rights in December 2000 under an agreement with BresaGen Ltd (Adelaide, Australia); -- MG98: currently in Phase II trials in various cancers. British Biotech was granted exclusive European development and commercialization rights in February 2002 under an agreement with MethylGene Inc. (Montreal, Canada); and -- BB-10153: now entering Phase II studies in heart attack patients. In research, British Biotech has two ongoing programs and access to a third a follows: -- an Antibiotic Program based on peptide deformylase inhibitors (PDFIs). The objective is to start the clinical program in patients with serious chest infections in 2002; -- a research collaboration with Serono SA (Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland) to identify new treatments for serious inflammatory diseases, particularly multiple sclerosis; and -- an exclusive option to take up European development and commercialization rights over MethylGene's cancer research program in small molecule inhibitors of DNA methyltransferase. British Biotech also has collaborations with Schering-Plough Corporation, OSI Pharmaceuticals, Inc., DevCo Pharmaceuticals Ltd and Tanabe Seiyaku. For more information, visit http://www.britishbiotech.com or call 212-696-5600. |
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