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
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