Vienna, Austria (PRWEB) August 31, 2006
For Austrianova, this study is a valuable basis for further product developments outside the Company’s core focus of oncology. It validates its proprietary technology by demonstrating that it is well suited for microencapsulation of any type of living cells. In clinical studies of its reference product, NovaCaps®, which is the first encapsulated cell product targeting difficult to treat solid tumours, no adverse events related to the delivery of the capsules were noted. The microencapsulated cells have also been shown to stay active and survive for several months. Austrianova is the only company worldwide to have an IP protected industrial GMP production line for the encapsulation of living cells in cellulose sulphate with an easy upgradeable capacity of 36 000 vials a year which allows the facile yet reproducible manufacture of other follow-on encapsulated cell products at industrial scale.
Major benefit: autoregulation of insulin production
This innovative approach opens up new and very promising medical options for the treatment of type 1 diabetes: Insulin substitution could be achieved by transplanting microencapsulated cells producing insulin. Up to 1.2 million people worldwide are affected by diabetes mellitus type 1, an autoimmune disease destroying pancreatic islet cells. Despite intensive insulin substitution about one third of all patients suffers from poorly controlled blood glucose levels and will most probably develop long-term diabetic complications. Encapsulated insulin-producing cells will react to the physiological stimuli of blood sugar levels, essentially mimicking the natural regulation of insulin levels. Thus, diabetes could be relieved of the current problematic dosing issues. As a further advantage, the transplanted encapsulated cells are effectively protected from attacks by the immune system so that rejection of the cells does not occur, thus there is no need to use immune-suppressive drugs.
Advantages of cellulose sulphate in cell encapsulation: "We are excited by this data since it provides yet another example of the suitability of cellulose sulphate for encapsulated cell products," says Brian Salmons, Managing Partner for Science and Technology. Cellulose sulphate is ideal for encapsulation of cells since it produces robust capsules that show excellent biocompatibility, with no signs of inflammation upon their implantation. Austrianova has been able to successfully address the issues that hampered the successful clinical and commercial application of cell encapsulation by developing a novel manufacturing process for cellulose sulphate which resulted in material with superior properties as compared to conventional cellulose sulphate available on the market. The Company’s encapsulation technology has been optimized so that all components and production steps are standardized and of reproducible quality.
Further advances in development
Austrianova is convinced that implantation of encapsulated cells has the potential to treat a wide variety of chronic or genetic diseases such as peripheral vascular diseases or haemophilia. The company is already negotiating with biotech and pharmaceutical companies to co-develop encapsulated cell products to treat diabetes. "This validates the versatility and thus the commercial potential of our encapsulation technology," states Thomas Fischer, Managing Partner for Finance and Administration. The overall market for diabetes products is expected to increase to almost € 14.5 billion by 2007 and the growth potential of the diabetes type 1 market is estimated to 5 – 6 percent.