21st Apr 2005 07:00
BTG PLC21 April 2005 BTG plc: Update on Varisolve(R) London, UK, 21 April 2005: BTG plc (LSE: BGC), the IP and technologycommercialisation company, announces the following update on Varisolve(R), thepotential new treatment for varicose veins being developed by its subsidiary,Provensis. In January 2005, Provensis completed a one-year programme of preclinical studiesintended to enable resumption of the US clinical development of Varisolve(R).In March, Provensis submitted a complete clinical hold response based on datafrom the studies, together with the protocol for a proposed Phase II clinicalsafety study of Varisolve(R), to the US Food and Drug Administration (FDA). FDA has completed its review of the data and study protocol. FDA has notrequested any additional preclinical studies and has agreed conceptually withthe proposed clinical study protocol. It is anticipated that a revised clinicalprotocol taking into account FDA's comments and an updated Investigator'sBrochure will be submitted in the next few weeks. Pending this, theInvestigational New Drug Application (IND) remains on clinical hold. Provensis is continuing discussions with potential partners in order to secure aglobal development and commercialisation agreement. Sir Brian Fender, BTG's Chairman, commented: "Provensis has made good progresswith the Varisolve(R) IND. The completed programme of preclinical studies hasenabled the focus of the discussions with the FDA to move to the correctprotocol design for the proposed Phase II clinical study. We continue tobelieve that Varisolve(R) has significant commercial potential in the longerterm and, subject to FDA approval of the revised protocol, resumption of USclinical development would be a significant step forward." - Ends - For further information contact: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell/Lucy Briggs+44 (0)20 7575 1741 +44 (0)20 7831 3113 About BTG BTG creates value by investing in intellectual property and technologydevelopment, and in early stage ventures. We realise value through technologylicensing, patent assertion and sale of equity investment. Through amultidisciplinary approach, we apply intellectual property and commercialexpertise, together with specialist skills in science and technology, to createmajor product opportunities in the health and high tech sectors. BTG hascommercialised important innovations, including Magnetic Resonance Imaging,Multilevel Cell Memory, Campath(R) (alemtuzumab), the first monoclonal antibodytreatment for chronic lymphocytic leukaemia, and recombinant Factor IX bloodclotting protein. BTG operates through wholly owned subsidiaries BTGInternational Ltd and BTG International Inc in the UK and USA, respectively. Forfurther information about BTG, please visit www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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