MELBOURNE, Australia, Jan 10, 2008 - (ABN Newswire) - The Directors of Solagran Limited (ASX: SLA)(PNK: SOGRF) are pleased to announce that the Russian Agency for Patents and Trademarks has accepted a patent application submitted by Solagran covering the use of Bioeffective(r) A in the treatment of Helicobacter pylori infection. If awarded, the priority date for this patent will be 26 December, 2007.
Solagran announced some time ago that the Pasteur Institute had undertaken initial trials to investigate the potential of Bioeffective(r) A to inhibit the growth and reproduction of Helicobacter pylori - the bacterium responsible for stomach and duodenal ulcers, as well as atrophic gastritis which often leads to cancer of the stomach.
The Director of the Pasteur Institute, Professor Anatoly Zhebrun DSc, was in Australia in August 2007 to discuss the results of these invitro trials and to clarify arrangements for phased clinical trials covering the use of Bioeffective(r ) A in both the prevention and the treatment of H.pylori infection, as well as conditions associated with this infection. The Pasteur Institute believes that there is a high probability that Bioeffective(r) A can both eradicate H.pylori and at the same time normalise microflora in the gastrointestinal tract - effectively replacing the antibiotics employed in the triple therapy currently used to treat H.pylori infection.
A number of other trials have now been conducted which point to a quite comprehensive role for Bioeffective(r) A in the treatment of conditions associated with H.pylori infection - particularly cancer of the stomach. These include:
- A series of animal trials that demonstrated the broad spectrum anti-carcinogenic activity of Bioeffective(r) A. The key finding of these trials was the extent to which treatment with Bioeffective(r) A reduced the incidence and the multiplicity of a range of tumours in experimental animals, particularly ca ncers of the stomach and breast,
- A human clinical trial during which it was observed that treatment with Bioeffective(r) A reduced the incidence and the severity of myelosuppression (the reduction in blood cell production in bone marrow) in patients undergoing cytostatic chemotherapy, and
- A comprehensive animal trial that clearly indicated a rare but valuable ability for Bioeffective(r) A to be used both prior to and during chemotherapy to reduce myelosuppression and other toxic side effects of this form of cancer treatment.
It was announced at the AGM in December that a summary of the results of each of these trials would be released to the market as soon as possible, with the full results being published in an appropriate international peer reviewed journal. The results of the H.pylori trials undertaken at the Pasteur Institute will be released once the patent approval process is complete.
The Directors wish to emphasise t hat this patent application represents a very significant move strategically for Solagran. It constitutes the first step towards changing the status of Bioeffective(r) A from a complementary medicine substance, to a registered pharmaceutical effective in many indications that would each warrant a pharmaceutical classification.
The planned clinical trials to study the ability of Bioeffective(r) A to prevent and treat H.pylori infection, and at the same time treat pre-cancerous atrophic gastritis arising from H.pylori infection, plus further trials to establish its ability to prevent myelosuppression in cancer patients undergoing chemotherapy, and combined with known anti-oxidant, immune stimulating and microflora normalising properties, suggest a comprehensive role for Bioeffective(r) A in treating inflammatory conditions of the gastrointestinal tract and in assisting in the treatment of cancerous conditions. These trials will provide sufficient evidence for ph armaceutical registration as a treatment for a number of specific GI indications. It will be up to Solagran to choose which ones to register. A successful ischemic heart condition trial completed recently in experimental animals will give rise to a further indication that would also warrant a pharmaceutical level classification for Bioeffective(r) A.
This move towards full pharmaceutical registration will give further weight to the statement made some time ago by the Directors to the effect that, because of the size of the markets involved, they believed Bioeffective(r) A would be as valuable to Solagran's product portfolio as Bioeffective(r) R in the longer term. In some cases, a combination of these two Bioeffectives(r) is likely to constitute a particularly powerful therapy - as was demonstrated in the recent myelosuppression trial.
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