Tripep starts first clinical placebo controlled phase I/II study of alphaHGA in HIV-positive patients

Tripep today confirmed that it has received all necessary approvals from the Thai authorities in order to commence the company’s first phase I/II study of alphaHGA. alphaHGA has a novel, unique mode of action against HIV and has in the preclinical setting displayed effect on both regular HIV-strains as well as HIV-strains multiresistant to other HIV drugs. The study is planned to commence within the next two weeks and will be conducted at the Ramathibodi Hospital, which is associated with Mahidol University in Bangkok. The study will be monitored by a well renowned international CRO company, and will be conducted according to international standards, i.e. GCP (Good Clinical Practice). The purpose of the study is to compare the tolerability and safety of alphaHGA at different dose levels. In the study each group of patients is treated (12 with active substance and 4 with placebo) for four weeks and is then followed for another four weeks. The study is designed as a double blind study which means that neither the physician nor the patient knows if the patient receives the active substance or placebo. The screening of patients for the first treatment group has been done and this group of patients will start their treatment within the next two weeks. After the first group of patients have been treated a safety evaluation will be performed, and then the other groups of patients will be initiated. Importantly, the trial will be performed on HIV-positive patients providing efficacy data for alphaHGA in HIV. Tripep estimates that the result of the study will be available during the second quarter of 2006. “Starting this study means that we now for the first time will get information on the effect of alphaHGA, which has a unique mode of action in comparison with existing HIV drugs, in HIV-positive individuals. If we get a positive result it will be a very important step towards commercialisation of alphaHGA” says Tripep’s CEO Jan Nilsson.