FDAnews
www.fdanews.com/articles/97148-biodiem-completes-treatment-in-phase-i-ii-study-of-bdm-e

BioDiem Completes Treatment in Phase I/II Study of BDM-E

August 14, 2007

Australian biopharmaceutical development company BioDiem announced the last patients in the Phase I/II clinical trial for its peptide BDM-E had completed treatment and follow-up assessments.

According to BioDiem, the BDM-E Phase I/II trial is a double-blind, placebo-controlled study of the efficacy and safety of BDM-E in the treatment of diabetic macular edema.

The company said that 188 patients have now completed the study, which involved 10 days of treatment with BDME and follow up safety and efficacy assessments at days 17, 40 and 100.

Data from the 13 sites involved in the investigative clinical trial across Russia will now be collected, the company added.

Although the efficacy results will not be known until the data is unblinded and reported in November, no patient experienced any significant adverse effects attributed to BDM-E, according to the company.

BioDiem said it expects to report in November.