Independent clinical study for Solagran's Bioeffective R

By Ruth Beran
Tuesday, 21 June, 2005

The Centre for Neuropsychology at Swinburne University of Technology will conduct an independent study, subject to ethical approval, for botanical biotech Solagran (ASX:SLA) to examine the neuro-cognitive, mood and brain EEG effects of Bioeffective R.

Bioeffective R is originally derived from green conifer needles. It is made up of polyprenols, which are naturally occurring precursors of dolichol, a substance found in all of the vital organs of the human body that plays an essential role in cell metabolism and supporting the immune system.

The randomised double blind placebo controlled study at Swinburne University will determine the efficacy of a 90-day administration of Bioeffective R on 120 healthy elderly volunteers aged 65 years and older.

"This is really going to be an efficacy trial on healthy volunteers, and this is pre-Alzheimer's. So they're not really showing full on Alzheimer's yet, they're just showing some mild cognitive impairment," said Solagran managing director Gene Litinsky.

Trials of Bioeffective R on 25 patients with advanced stages of Alzheimer's disease are currently underway at the Skvortsov-Stepanove State Psychiatric Hospital in St Petersburg, Russia.

"That trial is nearing completion, where we have very good preliminary indications," said Litinksy. "What we're looking to do here is replicate the Russian findings."

The Australian trial will be coordinated by Prof Con Stough of Swinburne University and is expected to begin in August, once ethical approval has been granted, and to be completed in the last quarter of 2005.

Bioeffective R as a liver treatment

Phase II clinical trials of Bioeffective R for the treatment of chronic hepatitis and other diseases of the hepatic biliary tract were recently completed in Russia.

"What we're looking to do is register the substance initially in Russia as a hepato-protector (liver protector)," said Litinksy. "Eventually we plan to do registration of the product in Australia."

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