Ceramisphere

Ceramisphere’s Healthcare R&D projects are currently centred on the encapsulation and delivery of therapeutic molecules. More specifically, we have investigated two specific commercial opportunities where there is a well-defined need for delivery technology, namely, (1) Delivery of siRNA, and (2) Oral delivery of peptides and proteins.

A major misconception about silica particles as a delivery system for human therapeutics, is their poor biodegradability. In fact, Silica synthesised by the sol-gel process has been found to be completely biodegradable.

A number of studies in the literature, show the dissolution of silica both in vitro and in vivo over periods of hours or days, depending on the surface area of the silica particles and the environment in which they are located. A 29Si tracer study revealed that the dissolved silicon diffuses through the blood stream or lymph and is excreted in the urine. The in vitro dissolution of Ceramisphere’s silica particles has also been demonstrated using standard flow-through dissolution methods (USP4) with significant in vitro dissolution (up to 50%) observed within 6 hours. (See also: Biodegradability of sol-gel silca nanopaticles. )

To date, Ceramisphere has demonstrated that it can:

• encapsulate DNA and RNA in silica micro-particles and protect these fragile biological molecules from enzyme degradation
• deliver these particles into cells in tissue culture (in vitro), and
• demonstrate endosomal release of silica particles and RNA in tissue culture.

Ceramisphere is currently conducting animal trials to show that silica micro-particles containing RNA can be injected into animals and, by delivering the RNA inside cells, demonstrate “gene knockdown” in vivo.

To date, Ceramisphere has demonstrated that it can:

• encapsulate proteins (e.g. Insulin) in silica micro-particles and show that the encapsulated protein is protected from degradation in the stomach and upper intestine (i.e. survives the presence of acid and pepsin) and,
• show that oral administration of micro-particles containing Insulin to diabetic rats, produces a positive effect relative to untreated Controls.

Recent experiments, in collaboration with the CSIRO, using fluorescently labeled particles, have demonstrated that Ceramisphere’s micro-particles are taken up through the intestinal walls into the general circulation. This confirms the ability of our technology to deliver proteins orally and opens up new opportunities such as oral vaccination.

Ceramisphere’s success in the development of its technology for the delivery of therapeutics will depend on partnerships with pharmaceutical companies. Thus, we are working with such companies to generate the pre-clinical data that is needed to prove efficacy.

The Ceramisphere technology represents true innovation and has the potential to provide unique opportunities through collaborative development in the Healthcare field, in particular for the delivery of therapeutic peptides. New collaborative opportunities would be considered.