The FDA intervened in 2003 to stop trials of Varisolve amid fears that the treatment could increase the risk of embolism in patients.
In March 2005, Provensis submitted data from a one-year program of preclinical studies aimed at enabling resumption of Varisolve’s US development, together with the protocol for a proposed phase II clinical study. The FDA requested amendments to the protocol, which were submitted in May 2005. 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.
Louise Makin, CEO 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 commercialization partner for Varisolve.”