Solagran Limited Solagran Limited ACN 002 592 396 Level 11 492 St Kilda Road Melbourne 3004 Victoria Australia Tel 61 3 9820 2699 Fax 61 3 9820 3155 10 March, 2005 Company Announcement Detailed Phase II Clinical Trials Results Exceed Expectations The Directors of Solagran Limited are pleased to announce that the Company has received the final report on the results of the Phase II clinical trials of Bioeffective R in the treatment of chronic liver disease that were completed in late 2004. The Directors consider the trials results to be extremely positive. The final report from the Medical Academy of Postgraduate Studies in St Petersburg (MAPS), which was compiled by Professor Inna Gavrisheva, the clinical trials coordinator (Dr Med. Sci, Head of MAPS Postgraduate, Doctoral and Scientific Programs and Member of Committee on Issues in Preclinical and Clinical Trials of Pharmaceuticals at the Federal Inspectorate of Healthcare and Social Development), and issued under the authority of Professor Tatiana Trofimova (Vice Chancellor for Science and Publishing at MAPS) confirms all of the initial findings which were announced to the market on 16 November, 2004. It also opens up the possibility of Bioeffective R being used for a range of other therapeutic applications and suggests that trials be undertaken to confirm this potential. The final MAPS report concludes that Ropren (the finished form pharmaceutical containing Bioeffective R) is both safe and effective, and recommends that Ropren be registered as an active hepatoprotector for prevention and treatment of chronic hepatobiliary system disease. The results of these clinical trials, together with the recommendations from MAPS, will now be submitted to the Russian Ministry of Health and the Russian Pharmacopoeial Committee as part of the process of registering Ropren and gaining entry into the Russian Pharmacopoeia. Subject to acceptance and approval by the Russian Ministry of Health, Solagran will be in a position to generate a revenue stream from sales of Ropren in Russia as a hepatoprotector before the end of 2005. The recommendation to move forward with the use of Ropren in clinical practice to treat chronic liver disease was based in part on the results of a much wider range of pre-clinical and pilot trials undertaken with Bioeffective R. Some of the results from these trials have been reported to the market previously. Other trials have been conducted in St Petersburg in conjunction with the Phase II clinical trials. Earlier preclinical and pilot clinical trials established that Bioeffective R is practically nontoxic, does not cause any pathological changes in biochemical indices, and does not have any negative effects on main physiological systems or internal organs. The finished form does not have any irritant or allergenic properties. Study of specific activity demonstrated that the drug has an expressed hepatoprotective effect, normalises the condition of hepatic parenchyma, increases haemoglobin levels, normalises lipid metabolism and has immunomodulating properties. The recent trials confirmed the clinical and laboratory efficacy and safety of Ropren in the treatment of liver damage. Efficacy was demonstrated through improvement in general condition, improved mood and appetite, normalisation of liver-related blood parameters - 2 alanine aminotransferase (ALT), asparagine aminotransferase (AST), bilirubin and protein fractions, a reduction in the size of the disease-enlarged liver and an increase in haemoglobin and erythrocyte counts. The final report also revealed a number of quite remarkable new findings relating to the effect of Ropren on liver function and blood sugar metabolism, as well as uncovering significant antioxidant and adaptogenic properties. These findings are summarised below. Liver Function Analysis of enzyme content in blood plasma (which characterises hepatocyte function) showed highly elevated levels of ALT and AST before beginning of treatment. After completion of the 12 week treatment course, this index returned to normal levels in patients treated with both Ropren and the comparator. However, positive changes in ALT levels were noted after 4 weeks in the group treated with Ropren, versus 8 weeks for the comparator group. Changes in AST activity were of a similar nature, being evident after 6 weeks of treatment with Ropren, compared with 8 weeks for the comparator group. Changes in gamma glutamyl transferase or GGT (a microsomal enzyme that is elevated in 70-80% of alcohol abusing patients and those with hepatobiliary disease) were clearly evident. Before treatment, the average level of this parameter in patients involved in the trial was 7.4 times the normal upper limit. Over the 12 weeks of treatment, GGT gradually returned to normal levels. Blood Sugar Metabolism Before the start of treatment, fasting blood serum glucose levels in both groups exceeded the upper normal limit by an average of 11%. For patients treated with Ropren, normalisation of this indicator of carbohydrate metabolism was noted at practically all treatment stages. After both the 8th week and the 12th week, there was a statistically significant difference from the initial values. In the comparator group, the difference from the initial level was not statistically significant. At the same time, no changes in blood protein fractions were noted, confirming the safety of application of Ropren. Before the start of treatment, analysis of blood lipids in both groups showed dislipoproteinemia (imbalance in cholesterol levels). The total cholesterol content exceeded the normal upper limit by 9% on average in the experimental group and by 5% in the comparator group. After 12 weeks of treatment, this parameter of lipid metabolism was normalised in both groups. The same trend was observed for extremely low density cholesterol. As early as 6 weeks after beginning of treatment with Ropren, an increase in high density cholesterol content was evident in the experimental group when compared with both initial values and those from the comparator group – an extremely interesting and important finding. Study of changes in triglycerides content in blood serum conducted over the 12 weeks of the trial did not show any pathological changes (either before or after treatment with Ropren and the comparator) indicating that Ropren does not impact triglyceride synthesis or biodistribution. A reduction in the Atherogenic Coefficient (AC, an index for estimating the risk of developing atherosclerosis) from 3.6 before the trials to 2.2 in the experimental group and 3.2 in the comparator group after 4 weeks was statistically significant (*ð<0.05) – as illustrated in Table 1. 3 Table 1 – Changes in Atherogenic
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