13 October, 2004Company AnnouncementUpdate on Phase II Clinical...

13 October, 2004
Company Announcement

Update on Phase II Clinical Trials of Bioeffective R

The Directors of Solagran Limited are pleased to announce an update on the clinical trials program in relation to the use of Bioeffective R for the treatment of chronic liver disease.


As announced by the Company on 11 March, 2004 Bioeffective R is currently being trialled on 120 patients at the following 4 centres in St Petersburg:

- Department of Gastroenterology, St George Hospital

- St. Petersburg Medical Academy of Postgraduate Studies (MAPS)

- S.P. Botkin Municipal Infections Diseases Hospital

- The Centre for the Prevention and Treatment AIDS and Infectious Diseases


At this point, the status of the trials is as follows:

- The trial at the St George Hospital is completed on all 30 patients, as planned.

- At MAPS, 14 of the 30 participants have completed the trial. 12 more will finish in October. The remaining 4 will complete the trial in the first half of November.

- At S.P. Botkin Hospital, 7 participants have completed the trial, 16 will finish in October and 7 in November.

- At the Centre for Prevention and Treatment of AIDS, 4 patients have finished, 22 will finish in October and 4 in November.


In total, 55 participants have already completed the trials, 50 will finish in October and the remaining 15 will finish in November.

To date, no patients have withdrawn from the trial. There have been no recorded Adverse Drug Reactions (ADRs), unforeseen events, side effects, or negative subjective comments reported by the 55 patients who have completed the trial.

The results of these double blind, randomised, placebo controlled comparator trials will be available once the remainder of the patients finish the trials and statistical analysis of the data is complete.


Peter Stedwell, Director
On behalf of the Board of Directors