BresaGen soars on Parkinson's results

Australian stem cell company BresaGen (ASX:BGN) has demonstrated functional recovery from the effects of Parkinson's disease in a rat model treated with human dopaminergic neurons derived from human embryonic stem cells.

The announcement was greeted by a substantial rise in the company's share price, jumping more than 25 per cent at the time of writing from an opening price of $AUD0.345 to $AUD0.435.

"This puts the company in the forefront of companies developing therapeutics from human ES cells," said BresaGen CEO Dr John Smeaton. "It's a big step forward for the field."

The study used a well-established and FDA-accepted rat model for Parkinson's, in which the animals were treated with 6-hydroxydopamine to ablate the substantia nigra, causing brain lesions which result in Parkinson's-like effects.

Within eight weeks of the implantation of the human ES cell-derived neural cells, the rats showed a significant reduction in the effects of the disease symptoms, as well as an increase in dopamine-producing cells.

"This is the first time that reduction of the effects of Parkinson's disease has been reported using neural cells derived from human ES cells in a commercially viable way," said medical director Dr Chris Juttner.

"What we've been able to demonstrate is that there is a very statistically significant reduction in the circling behaviour induced by amphetamines. We've also been able to demonstrate the presence of TH-positive dopaminergic neurons."

Pending further confirmation of these results, the company plans to publish the study in an appropriate peer-reviewed journal later this year, according to Juttner.

Previously, other researchers have demonstrated that mouse ES cells can reverse the effects of the Parkinson's symptoms in the rat model, but other human ES cell-based studies have used methods too complex for clinical viability.

However, according to Juttner, BresaGen has also developed proprietary methods for generating the cells using processes suitable for commercial production.

"The reason for the emphasis on the commercial significance is that we have developed a simple, GMP-compatible process to produce the TH-positive pre-dopaminergic neurons in vitro," he said.

CEO Smeaton said the result moved the company significantly closer to the clinic. "From the company's point of view, there are now quite a few things that can be done. The pathway to getting into clinical trials is now much clearer," he said.

Studies in primate models and safety studies would be the next phase in the development of a therapeutic process, leading up to an application to perform clinical trials. But more support of the technology by investors would be required to develop the product, Smeaton said.

"We're starting to see the technology point toward feasibility -- now we need funding," Smeaton said.