Thanks Homer, I've posted the announcement from SLA where they showed that their drug Bioeffective R was ggiven to an Aids sufferer for two weeks and the results showed a dramatic improvement to the sufferer with nil side effects. If SLA had released that announcement today they would be well over a buck. Anyway SLA's drug is still showing the goods against Alzheimers and many other diseases. Announcement below.
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
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 centres
presented a report containing their review of the results. Those present at the
meeting were:
Solagran Limited
Continued … Page 2 of 3
• 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.
Solagran Limited
Continued … Page 3 of 3
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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