Some good bits from the announcement today Solagran understands...

Some good bits from the announcement today


Solagran understands Bioeffective® A with its many components as well as any
conventional pharmaceutical company understand its single molecule
substances.


Dr Bespalov is a respected oncologist with some 230 publications in Russian and
international scientific journals. He is also the author of 10 books and
monographs. He has extensive experience in conducting clinical trials, and many
years experience working with Bioeffectives in the prevention and treatment of
both stomach and breast cancer.




At the Gastro 2006 Gastroenterology Symposium / Conference in St Petersburg
in May 2006, he presented a paper entitled Dietary Prophylaxis of Stomach
Cancer. This paper is related to the use of Bioeffectives in the treatment of
atrophic gastritis – a precancerous condition of the stomach. The paper is
available from the conference proceedings and a translation of the abstract is
attached.





Also attached is a paper that Dr Bespalov wrote in conjunction with his
predecessor as Head of the Cancer Chemoprophylaxis Group at the Institute of
Oncology. This paper reviews and summarises the results of recent trials
conducted in Russia with Bioeffective® A.

It is important to appreciate that this paper covers only the more recent trials
with Bioeffective® A. At the time that Solagran submitted its application to have
Bioeffective® A approved for use in products listed on the on the Australian
Register of Therapeutic Goods (ARTG), under the name Conifer Green Needle
Complex (CGNC), there had been a total of 49 human clinical trials conducted
with Bioeffective® A in Russia.

These comprised:

• 36 oral ingestion trials involving a total of 3,630 people with ages ranging
from 7 to 84 years, and
• 13 topical use trials involving a total of 2,079 participants ranging in age from
19 to 70 years.

No side effects from the use of Bioeffective® A were evident from any of these
trials, although there were 6 cases of individual intolerance encountered when it
was applied topically in concentrations well above that required for therapeutic
efficacy.




While in Australia, Dr Bespalov will progress negotiations in relation to:
• A series of phased multi-centre clinical trials to be conducted by the Pasteur
Institute with the participation of Dr Bespalov. These trials will be aimed at
achieving full pharmaceutical registration in Europe for Bioeffective® A in the
prevention and treatment of H.pylori infection and associated conditions
(including H.pylori infections in the oral cavity), and
• Clinical trials to be conducted at the Institute of Oncology involving the use of
Bioeffective® B to treat prostate cancer