HIV progress for BioInvent
BioInvent, from Lund, Sweden, has reported that it continues to make progress toward the clinical phases with its product candidate, BI-201, for the treatment of HIV infection.
BioInvent, from Lund, Sweden, has reported that it continues to make progress toward the clinical phases with its product candidate, BI-201, for the treatment of HIV infection.
The company says the toxicology reports show that the product fulfils the safety requirements and can be administered to humans. The results and other data have been compiled and submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK with an application for permission to start clinical trials, hopefully during the first half of 2005.
The resistance data presented at the 12th conference of retroviruses and opportunistic infections in Boston in February supported BioInvent's claim that BI-201 will not permit the development of resistance. The development of resistance to today's drugs is a growing problem. Patients develop resistance to the treatments and additionally there are recent reports of multi-resistant viruses being transferred from person to person. Hence it is a great need for new drugs with more favourable resistance profiles than today's therapy options.
Based on the data the company has obtained so far, it expects to enter the clinical phase with a product candidate with the potential to be a new class of drug for the treatment of HIV infection.
BioInvent
BioInvent develops antibody-based drugs against diseases where there is a significant unmet medical need. The antibody field is a strongly growing segment in the pharmaceutical market. BioInvent focuses on discovery and development of proprietary antibody-based drugs and to document their effect in pre-clinical and early clinical trials. Clinical development, marketing and distribution are conducted in cooperation with pharmaceutical companies. Today BioInvent conducts innovative proprietary drug projects in the areas of HIV-infection, thrombosis, cancer, atherosclerosis, and diseases of the joints. The scope and strength of BioInvent's technology platform is also utilised by partners in the development of new drugs. BioInvent's partners include ALK-Abello, Antisoma, Celltech, GlaxoSmithKline, Igeneon, ImmunoGen, Orbus and XOMA.
HIV-infection/AIDS
HIV infection is one of the most serious epidemics of our time. HIV has a high degree of variability and adaptability. When a new treatment is introduced, the virus usually changes quickly and develops resistance to the treatment, making it ineffective. The Tat protein is vital for HIV's ability to replicate itself and spread to new cells. Antibody-based drugs against the Tat protein are expected to be able to neutralise its activity so that the level of HIV particles in the patient's blood is reduced to such an extent that the development of the disease will be arrested. The antibody that BioInvent develops is targeted to a part of the Tat protein that is unchanged (conserved) between different virus strains. The target protein circulates freely in the blood and is not directly connected to a virus particle. Thus, the virus's capacity to change and adapt to avoid the effect of the antibodies is eliminated. Based on the characteristics of the unique target protein, the company expects that the antibodies against these conserved parts of the Tat protein will avoid the development of resistance and will therefore have a lasting effect. The project is based on patent rights licensed in July 2002 from Thymon, USA.