Melbourne based biotech Solagran Limited (ASX: SLA) has announced an important extension to the successful neurodegenerative disorders trials it is conducting in both Melbourne and St Petersburg Since listing in August 2003, Solagran has been commercialising a range of natural pharmaceuticals known as Bioeffectives. These multiple molecule substances each have many applications but few if any side effects. They are obtained from green conifer needles using a patented extraction process. Solagran acquired the underlying intellectual property from the St Petersburg Forest Technical Academy in the late 1990s in a commercial arrangement that involved key scientists acquiring a substantial shareholding in the company. Further development enabled the company to acquire a comprehensive new global technology patent not long after it listed a little over three years ago. Solagran is now poised to lead world in production of this new category of pharmaceuticals, which includes a particularly valuable class of substance known as polyprenols. Solagran’s Bioeffective R is comprised entirely of polyprenols.
In 2005, Solagran conducted successful trials at St Petersburg’s Skvortsova-Stepanova Psychiatric Hospital using Ropren (the finished dose form of Bioeffective R) to treat Alzheimer’s patients. The results demonstrated that administration of Ropren for a four month period led to an average 38 percent improvement in cognitive function among patients who had been suffering from Alzheimer’s for between six months and four years. 44 percent of patients experienced an improvement in cognitive function of 50 percent or more. 24 percent experienced an improvement of 100 percent or more. The trials also demonstrated that treatment with Ropren resulted in the elimination of most other Alzheimer’s symptoms, including depression. It also led to a normalisation of the activity of key enzymes in blood plasma, which in the opinion of Solagran Executive Chairman Dr Vagif Soultanov, provides evidence of a link between liver degeneration and the incidence of neurodegenerative disorders like Alzheimer’s – something he has hypothesized for many years. (This might explain the relatively high incidence of these disorders in western society where liver degeneration arising from inappropriate diet, alcohol abuse, and the widespread consumption of prescription and over the counter drugs, is also relatively high.)
Following this and other studies in St Petersburg, further trials to understand Ropren’s potential were undertaken in Melbourne by Swinburne University’s Brain Sciences Institute on 100 healthy volunteers aged 60 to 85 years. The positive preliminary results of these trials were announced last November. They indicated that treatment with Ropren led to:
1. A 15 percent or more improvement in memory function and speed of recall. This was a significant uplift for healthy volunteers in this age group.
2. Significant improvements in liver function (particularly in its protein synthesising function) together with other blood biochemical indices.
3. A marked reduction in Low Density Lipoproteins (LDL) combined with an equally marked increase in High Density Lipoproteins (HDL). This has major implications for the potential use of Ropren as a treatment to normalise cholesterol levels.
4. No adverse outcomes or side effects.
The final report from the Swinburne University study is to be received by Solagran in mid February 2007.
While the Swinburne trials were under way, a further trial involving the use of Ropren to treat critically ill heroin-addicted chronic alcoholics was completed at the Skvortsova-Stepanova Hospital. While not yet released for reasons related to ongoing intellectual property protection work, Solagran says the findings from the trial are significant. Some feedback from the research team was announced in October 2006 – including a firm policy decision by the hospital to incorporate Ropren into its clinical practice for the treatment of drug induced psychoses and other conditions associated with alcohol and drug addiction.
As a direct result of the clinical outcomes achieved with that trial, Solagran has now reached an agreement with the Head Physician and scientific medical team of the Skvortsova-Stepanova Hospital to conduct a virtually identical trial using another of its family of 15 Bioeffectives – in this case Bioeffective A. Bioeffective A is already listed with the TGA in Australia, and is now the subject of an NDI application with the Food and Drug Administration in the USA.
Both Solagran and the research team at the Skvortsova-Stepanova hospital believe that use of Bioeffective A, either in conjunction with or as and adjunct to treatment with Ropren, could have the potential to produce a number of positive physiological and neurological clinical outcomes for alcoholics and heroin addicts. This could lead to a treatment regime involving a relatively short treatment with Ropren combined with longer term treatment with lower cost Bioeffective A.
The new St Petersburg trial involves 50 patients aged 18 to 60 years. It has already commenced and the final report will be delivered by June 1 this year.
While the focus of much of the recent research with Ropren has been focused on its use in the prevention and treatment of neurodegenerative disorders, Ropren has a wide range of applications. It has also been shown to enhance immune system response and has already completed clinical trials as a safe and highly effective treatment for chronic liver disease. It is expected to be listed in the Russian Pharmacopoeia for this application in March 2007. There are 10 million Russians with chronic liver disease so the initial demand is expected to be significant.
Solagran is currently gearing up for full scale commercial production. Once this production capacity is up and running, regulations will permit Solagran to directly supply three month courses of the drug for personal use to people in many countries throughout the world.
A Director of Solagran, Mr Peter Stedwell, told Australian Investor that the Board believed its international trials and market development strategy would soon generate significant revenues. “The entry of Ropren into the Russian Pharmacopoeia will be quite an achievement just four years after listing on the ASX. The trial results suggest that Ropren could be a leading product in a number of large international pharmaceutical markets in the relatively near future” Stedwell said.
The Solagran website is at www.solagran.com
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