Anadis Wins Approval to Initiate Phase IV Oral HIV Therapy Study
Anadis, a biopharmaceutical company, has announced that it has been informed by the Australian National Center in HIV Epidemiology and Clinical Research and the University of New South Wales, both in Sydney, that their institutional review board has approved a major, Phase IV multisite randomized double-blind placebo controlled study of the company’s new product, BioGard.
In the study, Anadis’s BioGard will be used alone and in combination with the new Merck anti-AIDS drug Isentress (raltegravir). This investigator initiated CORAL study is sponsored by the National Center in HIV Epidemiology and Clinical Research. BioGard is Anadis’s novel oral therapy that contains high affinity anti-LPS antibodies and was recently approved for use by the Australian Therapeutic Goods Administration.
The CORAL study is designed to demonstrate that Anadis’s BioGard, supplementing Merck’s newest anti-viral drug raltegravir (which is reportedly the first of a new class of HIV drugs to receive FDA approval, the integrase inhibitors), together and separately, can reduce gastrointestinal immune activation and allow rebuilding of immune competence in those HIV patients with continuing HIV viral replication.
Anadis is in advanced discussion with researchers from the US National Institutes of Health and their collaborating clinical partners for additional, complementary studies of BioGard in patients with newly diagnosed disease.
Oren Fuerst, vice president of business development at Anadis, said: “BioGard could potentially be used in both the developed and the developing world, and as an adjunct to all current antiretroviral treatments. While we could market BioGard on our own, we are in discussion with commercialization partners, and we expect to announce such deals after we obtain the results of the CORAL study, expected during calendar year 2009.”