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further positive indications for bioeffective r

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    12 January, 2005

    Company Announcement

    Clinical Trials Report Reveals Further Positive Indications for Bioeffective R

    The Directors of Solagran Limited are pleased to provide an update regarding the recently completed clinical trials program in relation to the use of Bioeffective R as a treatment for hepatitis and other liver diseases.

    The trials were supervised by the St Petersburg Medical Academy of Postgraduate Studies or MAPS (www.mapo.spb.ru) and were conducted in accordance with the latest international protocols under the authority of the Russian Ministry of Health. They involved 120 patients at four different medical centres in St Petersburg. They were structured as double blind randomised, placebo controlled, comparator trials on the efficacy and safety of Bioeffective R in the treatment of hepatobiliary system diseases.

    The Company announced on 16 November, 2004 that the clinical trials had been completed and that the initial results had indicated that Bioeffective R was a safe and effective preparation that could be used for both prevention and treatment of a range of liver diseases. No adverse drug reactions or side effects from treatment with Bioeffective R were reported. It was also noted that Bioeffective R started working significantly earlier than the comparator – one of the world’s most frequently used hepatoprotective substances. Professor Inna Gavrisheva, the Supervising Coordinator for the trials and Head of Doctoral, Post Graduate and Scientific Programs at MAPS, noted that Bioeffective R normalised the condition of the hepatic parenchyma, and normalised lipid metabolism by decreasing cholesterol as well as low and very low density lipoproteins.

    As part of the analysis of the clinical trials results, it was observed that the patients treated with Bioeffective R had displayed a number of positive indications in relation to general metabolism and the functional condition of organs other than the liver. After discussions with the company regarding these observations, two Solagran Directors, Dr Vagif Soultanov and Charles Pellegrino, flew to St Petersburg in mid December to meet with the scientists evaluating the results of the clinical trials. Both Directors attended a meeting where the head of each of the trial centers presented a report containing their review of the results. Those present at the meeting were:

    • From MAPS: Professor Tatiana Trofimova, the Vice Chancellor for Science, Professor Inna Gavrisheva and Professor Alexander Lila

    • From the Department of Gastroenterology at the St George the Sufferer Hospital: Dr Veronica Popova

    • From the S. P. Botkin Municipal Infectious Diseases Hospital: Dr Vasily Pilipenko

    • From the Centre for Prevention and Treatment of AIDS and Infectious Diseases: Professor Natalia Zakcharova, the Vice Director of the Centre

    • From the St Petersburg Forest Technical Academy: Professor Victor Roschin and Dr Alexander Raspopin

    • From Solagran: Dr Vagif Soultanov and Mr Charles Pellegrino

    It was reported that the trials had revealed a number of positive indications that were not expected by the scientists from MAPS and the other medical centres. Of particular interest were indications that treatment with Bioeffective R appeared to have a positive effect on the immune system and a normalising effect on protein, carbohydrate and fat metabolism – while at the same time exhibiting very obvious and significant anti-oxidant properties. The Solagran Directors were told by the scientists that they believed Bioeffective R may have the potential to assist in normalising blood sugar levels.

    One particularly interesting case discussed involved a terminally ill patient from the Centre for the Prevention and Treatment of AIDS and Infectious Diseases. Professor Zakcharova, one of Russia’s leading AIDS researchers who had recently returned from a high level research exchange program with AIDS experts in the US, apologised for introducing what could be considered subjective data, but then went on to say:

    “We requested that scientists from the Forest Technical Academy provide additional Bioeffective R to treat a patient outside the clinical trials program. This patient had AIDS and as a result, had related complications in the liver, pancreas and kidneys. The patient had shown no response to recognized treatments, and further exposure to these treatments was considered inappropriate given his terminal condition. After a two week course of treatment using Bioeffective R, we were surprised to observe that the patient’s condition improved dramatically. I want to thank Professor Roschin for providing the Bioeffective R, because it has enabled us to get the patient out of danger.”

    Professor Lila commented that patients treated with Bioeffective R did not experience any allergic reactions, and that all patients that received Bioeffective R during the trial expressed a strong desire to continue the treatment.

    After hearing reports from all centres, the Solagran Directors agreed to a request from MAPS that the final results to be presented to the Russian Ministry of Health should now be analysed with the participation of additional scientists from the AIDS Centre and the Endocrinology Department within MAPS. This will enable a thorough analysis to be conducted in relation to all of the results obtained. This full report is expected by the end of January, 2005 and should be released to the market by mid- February 2005.

    The Directors can confirm however, that on the basis of the results provided to date, Bioeffective R will be an effective substance for the prevention and treatment of liver disease. Once the final clinical trials report has been received, Solagran will apply to the Russian Ministry of Health to have Bioeffective R entered into the Russian Pharmacopeia. Once this occurs, the substance will be available for prescription in Russia. Solagran, together with scientists from its research partner (the St Petersburg Forest Technical Academy) and our pharmaceutical manufacturing partner in St Petersburg (Galenopharm) are well advanced with the preparation of all documentation necessary for a pharmacopeia entry.

    A comprehensive review of the future clinical trials program for Bioeffective R will be undertaken during the first quarter of 2005, after a full analysis of all the positive indicators that have emerged from the recently completed trials.


    Peter Stedwell, Director


    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 results suggest Bioeffective R has a very positive impact on damaged liver cells.
 
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