http://www.pharmainfocus.com.au/CM antibacterial on launch...

http://www.pharmainfocus.com.au/

CM antibacterial on launch pad

Posted 11 September 2006

A complementary medicine antimicrobial which its makers say is effective against both bacteria and fungi is set to be launched in the next six months.

Bioeffective A (conifer green needle complex), developed by Australian biotechnology company Solagran, includes Candida albicans and various methicillin resistant Staphylococcus strains among its targets.

Solagran says it is seeking a commercial partner to help market the product which Denis Kilroy, non-executive-director and strategic advisor at Solagran, said had received TGA approval as a complementary medicine substance for topical and internal use earlier this year.

“We’re now looking for the right partners to run with it,” he added.

“We could also introduce it as an ingredient, we could introduce it as a capsule or in liquid form, we could introduce it under another pharmaceutical company’s name or do it ourselves, we are looking at all these options at the moment.”

In post-approval in vitro trials, Bioeffective A has been shown to inhibit the growth and reproduction of 28 strains of bacteria, and three strains of fungi, Solagran says. The company is also testing the agent’s ability to treat Helicobacter Pylori.

According to the company, the product has few side effects. In almost 50 clinical trials involving more than 5,700 patients aged 7-84 years, only six cases of intolerance were reported. All cases involved skin sensitivity when the topical application was applied in high concentrations, Solagran said.

The trials were all conducted in Russia with 36 being ingestion studies including two double-blind placebo controlled trials and five comparator controlled studies. None of the 13 topical trials were controlled.

“This should however be seen in context of their use. Many of these trials were conducted by military hospitals that were dealing with acute trauma injuries. Thus in these cases it would not have been ethical to withhold treatment to patients (i.e. by issuing them with non active substances). The other point of course to note here is the degree of confidence that these senior medical doctors must have had in Bioeffective A to utilise it as a treatment of choice,” Solagran said.