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BioDiem starts 4 new Monash studies with eye drug BDM-E |
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01 Sep 2007 |
Australian pharmaceutical development company BioDiem Ltd. today announced the commencement of four new studies at Monash University on peptide eye drug BDM-E
MELBOURNE, Australia | 31 August, 2007 | Australian pharmaceutical development company BioDiem Ltd (ASX:BDM) today announced the commencement of four new studies at Monash University on peptide eye drug BDM-E.
BioDiem CEO Tom Williams said, “These new studies are designed to expand on the remarkable results obtained at Monash in the recent pre-clinical model treating angiogenic types of eye diseases. These diseases such as the wet form of age-related macular degeneration (AMD) and diabetic retinopathy (DR) are the two largest causes of blindness in the western world.”
“Now we intend to broaden our reach into models of prevention as well as treatment. We will also test BDM-E in a model of eye disease that mimics the dry form of age-related macular degeneration. Although dry AMD is 4 to 5 times more common than wet AMD, there is nothing on the market to treat it, so obviously there is a strong medical and commercial incentive to assess the ability of BDM-E to treat this common condition in the ageing population.”
In another model of pre-diabetic animals BDM-E will be assessed for its ability to improve retinal inflammation and retinal function when the drug is given from the onset of diabetes.
Associate Professor Jenny Wilkinson-Berka at Monash will supervise the four new studies expected to be completed over the next 4 to 8 months.
Diabetes and diabetic retinopathy in Australia
The rate of diabetes in Victoria has almost doubled in the last five years and research shows that around 29% of diabetics over 40 years of age have diabetic retinopathy.
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.
There is currently no approved therapy available for Diabetic Retinopathy (DR). Intra-ocular steroids have been used off-label, but they are limited by major side effects such as the development of cataracts and glaucoma.
BDM-E is currently in a clinical trial in patients with DR that has recently completed treatment. Results are due in November 2007.
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”
SOURCE: BIODIEM |
