FDAnews
www.fdanews.com/articles/81531-miravant-starts-enrollment-in-trial-of-photrex

MIRAVANT STARTS ENROLLMENT IN TRIAL OF PHOTREX

October 10, 2005

Miravant Medical Technologies has reported that patient enrollment is underway in its Phase III clinical trial of Photrex (SnET2) for wet age-related macular degeneration (AMD). This multicenter, placebo-controlled study is a confirmatory trial designed to fulfill the requirements for additional clinical data as outlined in an approvable letter received from the FDA.

Miravant has contracted with Kendle to provide clinical development and trial management services for this study, which is being conducted at approximately 50 investigational sites in the UK, Central and Eastern Europe. This randomized, placebo-controlled trial includes a range of patients with both the classic and occult forms of wet AMD. Miravant expects to conduct a primary efficacy endpoint analysis at 12 months (one year after initial treatment), with a total of approximately 650 patients to be analyzed.