Following extremely encouraging Phase IIa clinical trial results showing successful tumor regression and safety in man, nanotechnology pioneer pSivida Limited is intensifying development of its fully patented invention of nanostructured bioactive, biodegradable and biocompatible silicon (BioSilicon™) for multiple potential healthcare applications.
This unique invention bridges the gap between electronics and healthcare and is the inspiration of Dr Leigh Canham, the world’s foremost authority on porous Silicon. pSivida’s major shareholder is Europe’s largest research institution, the UK Government’s QinetiQ Group plc (formerly the Defence Evaluation and Research Agency - DERA).
Successful Phase IIa clinical trial results, most recently in February 2005, showed 80% to 100% tumor regression with no product related adverse side effects. Multi-center Phase IIb clinical trials are expected to begin in June 2005. Strategic alliances secured during 2004, such as ITOCHU of Japan and a major international pharmaceutical group, in addition to the NASDAQ listing achieved in January this year, will intensify interest in pSivida, bringing the company to the attention of a much wider and more knowledgeable investor base.
‘Core Focus: Slow release controlled drug delivery and in-situ localized cancer therapy (brachytherapy)’
Although many definitions exist for nanotechnology, the National Nanotechnology Initiative (NNI) defines it as ‘nanotechnology’ only if it involves all of the following:
- Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range.
- Creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size.
- Ability to control or manipulate on the atomic scale. Medical researchers work at the micro- and nano-scales to develop new drug delivery methods, therapeutics and pharmaceuticals. For instance, DNA, our genetic material, is in the 2.5 nanometer range, whilst red blood cells are approximately 2.5 micrometers.