phase ii trials complete - results "very positive"

16 November, 2004
Company Announcement

Phase II Clinical Trials Complete on Hepatoprotective Properties of Bioeffective R


The Directors of Solagran Limited are pleased to announce, that Phase II clinical trials of Bioeffective R for the treatment of chronic liver diseases, initially announced by the Company on 11 March, were completed on schedule.

The summary results from these multi-centre, double blind, randomised, placebo controlled comparator trials on the efficacy and safety of Bioeffective R in the treatment of hepatobiliary system diseases are very positive.

The trials, conducted at 4 centres in Russia in accordance with the latest international protocols including GCP and GLP and coordinated by the Medical Academy of Postgraduate Studies (MAPS), studied the comparative efficacy and safety of Bioeffective R against that of one of the most popular hepatoprotective products in the world.

A total of 120 patients from different age groups and with different stages and types of liver disease participated in the trial. They were treated with either Bioeffective R or the comparator preparation for a period of 12 weeks.

Criteria for measuring the efficacy of the preparations included changes in the nature of subjective complaints (degree of expression of main clinical symptoms), improvement in the patients’ general condition and the degree of recovery of liver function as confirmed by laboratory studies. The data was statistically processed using generally accepted methods. The trials proved that Bioeffective R is very effective in treating diseases of the hepatobiliary system. Professor Inna Gavrisheva, the Supervising Coordinator for the trials and Head of Doctoral, Post Graduate and Scientific Programs at MAPS had the following comments: “The hepatoprotective action of Bioeffective R is due to the wide spectrum of biological activity of the preparation. It normalises the condition of the hepatic parenchyma, normalises lipid metabolism by decreasing cholesterol as well as low and very low density lipoproteins and functions as an immuno-modulator. One of the most important hepatoprotective actions of Bioeffective R is its ability to restore the liver’s protein synthesising function. It is also very interesting to note, that Bioeffective R started working significantly earlier than the comparator.”

Subjectively, the patients reported a noted improvement in general health, enhanced mood and emotional outlook, improved appetite and better quality of sleep. Laboratory analysis indicated, that by the end of the trial, most patients also showed a normalisation of biochemical indices (AST, ALT, bilirubin and protein fractions), a decrease in the size of the disease-enlarged liver and an increase in haemoglobin and erythrocyte counts. No adverse drug reactions or side effects from treatment with Bioeffective R were reported.

The trial proved that Bioeffective R is a safe and effective preparation that can be used for both prevention and treatment of various liver diseases. The Company expects to receive the complete results and individual data for all trial participants from these Phase II trials before the end of December. Based on the extremely encouraging results of the trials, Professor Gavrisheva made the following recommendations: “Bioeffective R should be registered as an active pharmaceutical hepatoprotector and implemented into medical practice for prevention and treatment of serious liver diseases.”

Peter Stedwell, Director

On behalf of the Board of Directors

Solagran Limited

Solagran Limited is an Australian company founded in 1995 with the objective of commercialising the results of a research and development program that commenced in Russia in the 1930s, and which has continued, uninterrupted, until the present day. The focus of the research program has been the extraction and utilisation of the “live elements” of tree foliage. Solagran has collectively trademarked these substances using the term Bioeffectives®.

Solagran’s technology permits it to obtain many different Bioeffectives from tree and plant sources. One of the highest value Bioeffectives is a class of organic substances known as polyprenols. Polyprenols are naturally occurring precursors of dolichol, which is found in all of the vital organs of the human body, and which plays an essential role in cell metabolism and in supporting the immune system.

Solagran has committed significant resources to the development and testing of Bioeffective R – a Bioeffective comprising polyprenols. Experimental and trials results show that Bioeffective R has a very positive effect on damaged liver cells.