Friday December 05 2008 | Biotechnology feed | All feeds
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Friday December 05 2008 | Biotechnology feed | All feeds
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Bioinvent's Candidate Drug Against Hiv/Aids Approved To Enter Clinical Trials In UK Lund, Sweden: 18 May 2005 - BioInvent (SAX: BINV) has obtained approval from the Medicines and Healthcare products Regulatory Agency in the UK to initiate the first clinical trial of BI-201, its drug candidate for the treatment of HIV-infected patients. This will be the first proprietary product from BioInvent’s broad portfolio to enter clinical trials. The phase I/IIa trial includes 36 HIV-infected patients who have not received any previous treatment. The primary objective is to study safety, tolerability and pharmacokinetic properties of the candidate drug. A secondary objective is to study the effect on the viral load and thereby get the first indication as to how effective an antiviral drug BI-201 may be. It is expected that the first patients will be recruited to the study soon and the results are expected to be presented in the second quarter of 2006. BI-201 is a human antibody selected from the Company’s n-CoDeR antibody library for its ability to bind to the TAT protein. This protein is vital for HIV replication and, by neutralising TAT activity, BI-201 is expected to prevent the spread of the virus between human cells. This action has been confirmed in in-vitro laboratory tests. Importantly, in drug resistance tests, BI-201 has been shown to inhibit the virus for 20 weeks without any development of resistance. The development of resistance is a major problem with all currently available HIV/AIDS treatments. HIV’s high degree of variability and adaptability means that the virus is able to change rapidly and usually develops resistance to treatments very quickly, rendering them ineffective. However, BI-201 acts on a protein outside of the infected cell, on a highly conserved epitope, meaning that resistance is much less likely to develop. In in-vitro tests that exposed the virus to the antibody for a long, continuous period of time, no resistance developed. The use of fully human antibodies also reduces the risk of side effects, a significant problem with current HIV treatments. “We have passed an important milestone with the entry of our first candidate drug into clinical development” commented Svein Mathisen, Chief Executive Officer of BioInvent. “In less than three years we have taken our HIV project through discovery to clinical studies, underlining the strength in our technology platform. The state of the art design of this first trial mean that we may have an indication of the drug’s antiviral effect in only one year’s time.” The double blinded, placebo-controlled trial will take place at Chelsea & Westminster Hospital in London, the UK’s largest HIV/AIDS clinic with approximately 4000 treated patient annually. The regulatory clearance from MHRA results in a milestone payment to the American inventor of the patents that protect BI-201. -- END -- For more information: BioInvent International AB Svein Mathisen Cristina Glad President and CEO Executive Vice President Phone: +46 (0)46 286 85 67 Phone: +46 (0)46 286 85 51 Mobile: 046 (0)708 97 82 13 Mobile: 046 (0)708 16 85 70 svein.mathisen@bioinvent.com cristina.glad@bioinvent.com Notes to editors: BioInvent International AB listed on the O-list of the Stockholm Exchange (Stockholmsbörsen) (SAX:BINV), develops therapeutic antibodies 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 therapeutic antibodies, and documenting their effect in pre-clinical and early clinical trials. Today BioInvent conducts innovative drug projects in the areas of HIV infections, thrombosis, cancer, atherosclerosis and diseases of the joints. The base for these projects is a competitive technology platform that covers the chain, from the n-CoDeRÒ antibody library, for fast selection of human antibodies to production in a facility that is approved for manufacturing biological drugs. The scope and strength of BioInvent’s platform is also utilized by partners in the development of new drugs. Such partners include ALK-Abelló, Antisoma, Celltech, GlaxoSmithKline, Igeneon, ImmunoGen, OrbusNeich and XOMA. The Company has 95 employees and operates in the Ideon Research Park in Lund. Legal disclaimer This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual out-come may deviate significantly from the scenarios described in this press release. BioInvent International AB (publ) Co. reg. no. 556537-7263
Visiting address: Sölvegatan
41 Tel.: +46 (0)46 286 85 50 |
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