13th Jul 2005 09:00
BTG PLC13 July 2005 BTG plc: Varisolve(R) given FDA approval to recommence US clinical trials London, UK, 13 July 2005: BTG plc (LSE: BGC), the medical innovations company,today announces that its subsidiary Provensis has received approval from the USFood and Drug Administration (FDA) to resume clinical development of Varisolve(R), which is being developed as a novel microfoam treatment for varicose veins. Louise Makin, Chief Executive Officer of BTG, commented: "We are very pleasedthat the US clinical development of Varisolve(R) can resume. Now that thepathway for further regulatory development in the US is clear, we look forwardto progressing discussions to secure a global development and commercialisationpartner for Varisolve(R)." In March 2005 Provensis submitted data from a one-year programme of preclinicalstudies aimed at enabling resumption of the US development of Varisolve(R),together with the protocol for a proposed Phase II clinical study. The FDArequested amendments to the protocol, which were submitted in May 2005 aspreviously announced. Following review of the amended submission, the FDA haslifted the hold on conducting clinical trials with Varisolve(R) in the US andapproved the Phase II study protocol. Enquiries: BTG plc Financial DynamicsAndy Burrows Ben AtwellTel: +44 (0) 20 7575 1741 Tel: +44 (0) 20 7831 3113 About BTG BTG acquires rights to early stage pharmaceuticals and other medicaltechnologies from a global network of corporations, universities and researchinstitutions. We apply resources including finance, intellectual property andproject management skills to fund and manage outsourced preclinical and clinicaldevelopment programmes. We then commercialise the technologies by licensing topharmaceutical or device companies, or by creating companies to exploit them.Our pipeline comprises around 50 assets at varying stages of development,contributing to an increasing range of products marketed by our licensees. BTGoperates from London, Philadelphia and Tokyo. For further information visit:www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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