We are pleased to announce that the Industry Research and Development (IR&D) Board has approved a grant to Metabolic under the Biotechnology Innovation Fund to undertake preclinical studies of candidate drugs for treating iron overload diseases.
The grant will provide up to $234,700 in dollar-for-dollar funding over 2 years.
PRELIMINARY DATA
We are also pleased to announce that animal experiments performed to date under this project have shown positive results. So far we have, obtained clear evidence that our current most favoured iron chelating compound (now codenamed MBP0201) is orally active, reliably enhancing iron excretion by the expected amount in rodents after oral administration. This is an encouraging indication that MBP0201 may provide an orally dosable treatment for iron overload conditions.
Next Steps Preparations are underway to conduct further preclinical efficacy and safety studies on MBP0201, and to appoint a contract manufacturer of bulk quantities of MBP0201 for animal toxicity and clinical studies.
ABOUT MBP0201 AND IRON OVERLOAD
In March 2002 Metabolic Pharmaceuticals entered into an exclusive license agreement with the Heart Research Institute (HRI) of Sydney to develop a drug for the treatment of iron overload diseases. The candidate drug is an iron chelating compound invented by Professor Des Richardson, then of the HRI, and coworkers, Prof Richardson is an international leader in iron metabolism. He has recently shifted his laboratory to the Children's Cancer Institute, affiliated with the University of New South Wales, where our research collaboration is now continuing.
Iron overload occurs when iron accumulates inside the body's cells to toxic levels. This is most often caused by either hereditary conditions or repeated blood transfusions in patients with severe anemia. Iron chelator drugs bind to iron and remove the excess iron from the body.
The iron chelator market, potentially worth up to US$350 million per annum, has long been dominated by a single treatment, desferoxamine ('Desferal') from Novartis. This drug has the disadvantage of being expensive to manufacture and inconvenient to administer, requiring either multiple daily injections or overnight infusions. There is a strong market need for an effective orally administered iron chelator.
Metabolic's candidate, iron chelator MBP0201 is easy to manufacture, appears to safely remove excess iron from inside cells and now have been shown in the recent rodent studies to be orally active.
Metabolic anticipates from its market assessment that a safe and effective orally administered iron chelator could
* compete very favourably with the existing treatments, and become the treatment of choice for controlling iron overload in the treatment of beta-thalassemia and sickle cell anemia;
* expand the market by becoming more often used in the treatment of patients with more common iron overload conditions, such as hereditary hemochromatosis. Hereditary hemochromatosis is the most common iron overload condition and one of the most common genetic disorders in the United States. About 0.5%, (approximately 1,000,000) of the US white population have this hereditary disorder, making them susceptible to developing iron overload. Most sufferers of this common condition currently are treated by phlebotomy (periodic blood-letting) to control their iron overload. A safe and effective oral iron chelator may contribute to a protocol change for the treatment of these patients.
ABOUT METABOLIC
Metabolic Pharmaceuticals Ltd (ASX:MBP) is a biotechnology company based in Melbourne, Australia developing a pipeline of pharmaceutical compounds to provide new drugs for world markets, Metabolic's most advanced compound is AOD9604 for obesity. The company recently completed intravenous Phase 2A clinical trials on AOD9604 with promising results, and expects to obtain and release results from an oral Phase 2A clinical trial by the end of August. AOD9604 directly affects the metabolism of fat and is an analog of a fragment of the human growth hormone: molecule. In addition to the iron chelating compounds which are the subject of this announcement, Metabolic is also assessing, in preclinical studies, compounds for the treatment of type II diabetes and osteoporosis.
Contact Details and Further Information
website www.metabolic.com.au Investor Relations David Kenley +61 3 9826 0949 Managing Director Chris Belyea +61 3 9826 0949.
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