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news.Immuron, a biopharmaceutical company focused on oral immunotherapy, has completed the treatment phase in its Phase 2 double blind placebo controlled clinical trial (the Coral trial).
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The trial was designed to test the Immuron hyperimmune antibody product BioGard as adjunct therapy to support the immune system of HIV patients undergoing long-term treatment with anti-retroviral drugs. The trial also involved the anti-retroviral drug Raltegravir in a combination of treatment regimes.
The trial was conducted by the National Centre of HIV Epidemiology and Clinical Research based at the University of New South Wales in Australia. All patients have completed their treatments and all trial samples are being processed at laboratories throughout Australia, including laboratories at the Universities of Melbourne and New South Wales.
Immuring said that the trial was sponsored by the National Health & Medical Research Council (NHMRC) via a major program within the National Centre of HIV Epidemiology and Clinical Research.
During the six month treatment phase within the Coral study, there was patient retention and compliance, with 68 of 73 participants finishing their allotted courses of treatment. Immuring is expected to release the full clinical trial results in June/July 2010 when all testing is completed.
The results will include both primary (immune marker measurements) and secondary (changes in plasma viral load and T cell counts) clinical endpoints. These results are expected to indicate the effectiveness of Immuring antibody product in improving immune markers both with and without the antiviral drug.
If the trial results are positive, Immuring is expected to partner with a pharmaceutical company possessing existing anti-retro viral drugs. Preliminary contacts with pharmaceutical companies have been made and will be accelerated when the trial results are known.
Grant Rawlin, CEO of Immuring, said: “We are delighted that this clinical trial has proceeded so smoothly within the expected time frame. We eagerly await the results, which if positive, due to the large global market for chronic support products for HIV patients, will have a positive impact for Immuring and also for the many patients being treated with anti-HIV drugs.”