BioDiem completes phase 1/ 2 blindness study

By Elaine Rigoli

Tampa, Fla., July 17 - BioDiem Ltd. said Monday that it has completed patient treatment and follow-up of patients in its phase 1/ 2 clinical trial to study of the efficacy of BDM-E in the treatment of diabetic macula oedema, a leading cause of blindness.

Although the efficacy results will not be known until the trial is complete and the data is revealed, the company said that no patient enrolled to date had experienced any adverse effects attributed to the study treatment. Only one patient has left the study, while the first 15 patients have completed the study, which involved 10 days treatment with BDM-E and follow up safety and efficacy assessments at days 17, 40 and 100.

"There are currently no approved drugs for treating diabetic retinopathy and although steroids are being used off label, they are often associated with serious adverse consequences like cataracts and glaucoma. So it's important to see that BDM-E is so far getting a clean bill of health with no serious adverse events in this trial," chief executive officer Tom Williams said in a news release.

The recruitment of patients took longer than anticipated and BioDiem is working closely with the Swiss Contract Research Organisation supervising the trial and a number of strategies are being employed to speed enrollment and boost the progress of the clinical trial, the release said.

BioDiem has recently received regulatory approval for additional clinical sites to expedite recruitment.

The objective of this clinical trial will be to demonstrate the safety, tolerability and efficacy of BDM-E administered by subcutaneous injections, in comparison with a placebo, in patients with clinically relevant diabetic macular oedema. The study endpoints will be changes in macular oedema measured by ocular coherence tomography and changes in visual acuity measured over a three-month observation period.

BioDiem said it is aiming to complete enrollment in the first quarter of 2007 and report the results in mid-2007.

BioDiem is a biopharmaceutical company based in Melbourne, Australia.

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