BTG PLC: VARISOLVE GIVEN FDA APPROVAL TO RECOMMENCE US CLINICAL TRIALS

Main Menu | News By Date | News By Supplier | News By Category | About Us

BTG PLC: VARISOLVE GIVEN FDA APPROVAL TO RECOMMENCE US CLINICAL TRIALS
26 September 2006 - BTG

BTG plc, the medical innovations company, today announces that its subsidiary Provensis has received approval from the US Food and Drug Administration to resume clinical development of Varisolve, which is being developed as a novel microfoam treatment for varicose veins.

Louise Makin, Chief Executive Officer of BTG, commented: “We are very pleased that the US clinical development of Varisolve can resume. Now that the pathway for further regulatory development in the US is clear, we look forward to progressing discussions to secure a global development and commercialisation partner for Varisolve.”

Provensis submitted data from a one-year programme of preclinical studies aimed at enabling resumption of the US development of Varisolve, together with the protocol for a proposed Phase II clinical study. The FDA requested amendments to the protocol, which were submitted as previously announced. Following review of the amended submission, the FDA has lifted the hold on conducting clinical trials with Varisolve in the US and approved the Phase II study protocol.

http://www.btgplc.com

About: BTG
BTG is an intellectual property and technology commercialisation company that operates internationally. BTG creates value by investing in intellectual property and technology development, and in early stage ventures. We realise value through technology licensing, patent assertion and sale of equity investments. Through a multidisciplinary approach, we apply intellectual property and commercial expertise, together with specialist skills in science and technology, to create major product opportunities in the health and high tech sectors. BTG has commercialised important innovations, including Magnetic Resonance Imaging, Multilevel Cell Memory, Campath (alemtuzumab), the first monoclonal antibody treatment for chronic lymphocytic leukaemia, and recombinant Factor IX blood clotting protein. BTG operates through wholly owned subsidiaries BTG International Ltd and BTG International Inc in the UK and USA, respectively.

More News:
  • For September 2006
  • From BTG
  • For Polymer OLED Devices