Stirling Products clinical trial listed on US websites

Wednesday, May 05, 2010

Pharmaceutical and healthcare company, Stirling Products (ASX:STI) has advised that its forthcoming TB, TB/HIV clinical trial, funded through a grant from the US Civilian Research & Development Foundation (CRDF) of its botanical immunomodulator ImmunoXel has this week been listed on the World Health Organization (WHO) and U.S. National Institutes of Health websites.

This will involve a double-blind, placebo-controlled clinical trial.

The U.S. Civilian Research & Development Foundation (CRDF) is a non-profit organization authorized by the U.S. Congress and established in 1995 by the National Science Foundation.

The company said the progressive recognition of ImmunoXel through this major US granting agency and through the WHO and NIH clinical trial registers this week mark important milestones in the continued development of ImmunoXel as a potential breakthrough immunomodulator for the treatment of all forms of TB, AIDS and TB/HIV.

The trial is now in process of being initiated following receipt of ethical clearance from the Office for Human Research Protections, of the U.S. Department of Health and Human Services and the completion of other preliminary formalities.

The WHO listing can be accessed at:

apps.who.int/trialsearch/trial.aspx?trialid=NCT01061593

And the U.S.National Institutes of Health Clinical Trials listing service at: clinicaltrials.gov/show/NCT01061593

In earlier published clinical trials, the Company said its botanical immunomodulating supplement, ImmunoXel, has been shown to be very safe and highly effective as an immune adjuvant in TB patients including patients with multi-drug (MDR-TB) and extensively drug resistant TB (XDR-TB).

Similar benefits were observed in patients with TB who were also dually infected with HIV (TB/HIV).

While these results were published in at least a dozen of peer-reviewed medical journals, no double-blind, placebo-controlled clinical trials have been conducted to date. This current CRDF assisted clinical study will allow investigators to carry out such a trial, the results of which are expected to become public toward the end of this year.

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