BioDiem completes treatment in phase I/II study of eye drug BDM-E: Results due November 07

BioDiem Ltd announced today the last patients in the phase I/II clinical trial for its peptide BDM-E had completed treatment and follow up assessments. Results are expected to be reported in November 2007

MELBOURNE, Australia | August 13, 2007 | Australian biopharmaceutical development company BioDiem Ltd (ASX:BDM) announced today the last patients in the phase I/II clinical trial for its peptide BDM-E had completed treatment and follow up assessments. Results are expected to be reported in November 2007.

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 macula oedema, a leading cause of blindness.

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, collated and entered into the database in a manner laid down by the international guidelines for conducting trials under good clinical practice (GCP) standards. The data will then be checked, validated and locked before the code is un-blinded and the statistics are analysed by the Swiss contract research organization supervising the trial.

Although the efficacy results will not be known until the data is un-blinded, and reported in November, it is already known that no patient in the trial has experienced any significant adverse effects attributed to BDM-E.

CEO of BioDiem, Mr Tom Williams said: "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 increased intraocular pressure that if untreated can lead to glaucoma. Also it is common for new drugs to fail at the hurdle of patient side effects or toxicity, so it is pleasing to see that BDM-E as it was administered in this trial was safe and well tolerated.”

“A safe and effective drug treatment for Diabetic Retinopathy could be expected to have major commercial potential, especially if it is administered by subcutaneous injection rather than the current standard, a direct injection into the eye”, Mr Williams said. BDM-E is delivered by subcutaneous injection in this trial, a manner familiar to diabetics with their administration of insulin.

The need for an effective treatment for diabetic retinopathy is being driven by an increased prevalence of diabetes which is at epidemic proportions. Vision impairment is a common complication of both Type 1 and Type 2 diabetes. Most patients with Type 2 diabetes eventually develop some degree of retinopathy. When diagnosed with diabetes, an individual’s risk of blindness is increased 25 times.

BioDiem has recently announced outstanding results in a pre-clinical model of angiogenic retinal eye disease independently conducted at Monash University. BioDiem is now reviewing forward plans for advancing the development of BDM-E to maximise the potential of the promising results obtained so far.

About the BDM-E Phase I/II clinical trial
BioDiem’s ‘proof-of-concept’ trial tests the ability of BDM-E to improve vision and the clinical signs of diabetic macula oedema.

188 patients from 13 centres in St. Petersburg, Moscow and elsewhere in Russia completed the trial. The study is being conducted in compliance with ICH Good Clinical Practice (GCP) guidelines. The trial is being managed by a Swiss contract research organisation (CRO) that specialises in executing clinical eye studies. Overview of the trial protocol:

Study End-points:

Primary: Changes in macular oedema measured by ocular coherence tomography (OCT)

Secondary: Changes in best corrected visual acuity (the current standard US FDA endpoint).

Key trial metrics:

-- 192 patients recruited and divided into two arms, comparing Study Drug with Placebo in a 1:1 ratio

-- Treatment arm receives 10ug of BDM-E once daily for 10 days. Patients are assessed at 7, 30 and 90 days after completion of treatment.

-- Delivery mechanism: Subcutaneous injection

-- Patients and Doctors are “double-masked

About Diabetic Retinopathy
There is currently no approved treatment available for Diabetic Retinopathy (DR). Intraocularsteroids have been used with some success in DR, but their use is limited by major side effects such as the development of cataracts and glaucoma.

Diabetes is a major metabolic disease reaching epidemic proportions in the developed world. Australia has more than I million diabetics and the rate is growing by 100,000 per year. Fears about the social and economic burden of a looming epidemic have led the federal, state and territory governments to agree recently to a $200 million program to tackle the disease. In the US over 20 million people (7% of the population) have diabetes.

Nearly all patients who have Type 1 diabetes for 20 years or more will have evidence of diabetic retinopathy. Up to 21% of people with Type 2 diabetes have retinopathy when they are first diagnosed with diabetes, and most will eventually develop some degree of retinopathy. In the United States, diabetes is responsible for 8% of legal blindness, making it the leading cause of new cases of blindness in adults 20-74 years of age. Each year, in the US, between 12,000 to 24,000 people lose their sight because of diabetes.

Retinopathy progresses from non-proliferative or background retinopathy to proliferative retinopathy. Proliferative retinopathy, the more serious form, occurs when new blood vessels branch out or proliferate in and around the retina. It can cause bleeding into the fluid-filled centre of the eye or swelling of the retina, and lead to blindness.

SOURCE: BioDiem Ltd

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