Eiffel claims trial confirms technology's promise

Melbourne drug-reengineering company Eiffel Technologies (ASX:EIF) says the results of a new pre-clinical study in an animal model confirm the early promise of insulin 'nanomised' by its proprietary supercritical fluid technology.

The trial, conducted by an independent research group at AGT Bioscience (ASX:AGT), was designed to confirm the effects of re-engineering commercial grade insulin for the treatment of insulin-dependent (type 1) diabetes.

A trial by Deakin University researchers last year provided the first indications that Eiffel's re-engineered insulin provides a more durable effect in lowering blood sugar than commercial insulin, at a significantly reduced dosage.

Eiffel said its in-house research has confirms not only that its technology reduces insulin particle size, but also it produces a new form of insulin that appears as stable as the unprocessed commercial product.

After reviewing the results of the original trial, Monash University diabetes expert Prof Paul Zimmet, head of the International Diabetes Institute of Australia, suggested that the enhanced effects might be explained by the re-engineering process yielding active, monomeric insulin molecules. Insulin occurs naturally as twinned molecules, or dimers, that dissociate in the body into the active, monomeric form.

Zimmet also reviewed the results of the AGT trial, and said the re-engineered product continued to show the promise seen in the earlier studies.

"The re-engineered insulin not only retains full activity in reducing blood glucose concentrations in the rats after supercritical fluid processing, but also appears to have an enhanced hypoglycaemic effect," Zimmet said.

Supercritical fluid technology can reduce the average diameter of drugs particle sizes by a factor of 100 to 1000, into the size range of tens to hundreds of nanometers, enormously increasing the drug's exposure to body fluids, according to Eiffel.

Conventional milling processes cannot achieve particle sizes below 1 micron (1000 nanometers).

More than 50 per cent of modern pharmaceutical drugs dissolve reluctantly in body fluids; Eiffel's 'nanomising' technology can improve their solubility, in some cases, by more than an order of magnitude. The technology opens up new options in drug delivery, including inhalation and transdermal absorption via drug-impregnated controlled-release patches.

Eiffel's technology produces particles of virtually uniform size, providing much greater predictability for drug absorption rates and activity profiles.

Eiffel's MD and CEO, Christine Cussen, said the company had initiated another AGT Bioscience study to determine the optimal dose for Phase I human clinical trials.

Cussen said a number of overseas drug companies had sent their proprietary protein therapeutics to Eiffel for experimental re-engineering. The company declined to confirm whether insulin, the world's most widely used protein drug, was among them.

Among the potential advantages of nanomised insulin, Cussen said, is that it could be delivered by inhalation, instead of injection, and because of its small particle size, would be less likely to clog the automated insulin pumps now preferred by many diabetics. Any increase in efficacy from nanomised insulin could also extend the recharging interval for insulin pumps.