BTI-322

BTI-322

An anti-CD2 monoclonal antibody which been in clinical trials to reduce or prevent steroid-refractory graft vs host disease.
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The progress reported today includes: * Resolution of Disputes with the Catholic University of Louvain The Company reached a resolution of its disputes with the Catholic University of Louvain (UCL) relating to UCL's license to BioTransplant of the BTI-322 rodent antibody and its human analogue, MEDI-507.
While this was a difficult decision for this Company to make, the filings were necessary to preserve and maximize the value of our intellectual property and, in particular, to avoid the potentially devastating effects of the attempted termination by the Catholic University of Louvain of our exclusive license to develop and commercialize BTI-322 and its human analogue, MEDI-507.
Under the terms of the research and license agreement, which BioTransplant and UCL entered into in 1993, BioTransplant received exclusive rights from UCL to develop and commercialize the BTI-322 rodent monoclonal antibody.
BioTransplant has retained the right to use BTI-322 and/or siplizumab in its proprietary ImmunoCognance(TM) systems, which are designed to re-educate the immune system to accept foreign tissue: the AlloMune(TM) System for human-to- human transplantation, and the XenoMune(TM) System for porcine-to-human transplantation.
Luc University Hospital in Brussels today announced the results of a phase I/II study demonstrating that adding the company's BTI-322 monoclonal antibody to a commonly used immunosuppressive therapy, including Prograf(R) (tacrolimus), reduced the incidence of rejection in human liver transplantation in the immediate post-operative period by 70% compared to Prograf(R) protocol alone.
In pilot clinical trials in over 100 patients in the United States and Europe, BTI-322 has suggested potential clinical benefit in the studied populations and has been generally well tolerated.
Nasdaq: MEDI) and BioTransplant Incorporated (Nasdaq: BTRN) today announced preliminary results of a Phase 1/2 clinical trial in which BTI-322 monoclonal antibody, given in combination with Prograf(R) (tacrolimus, a calcineurin inhibitor; Fujisawa) after liver transplantation, significantly lowered the incidence of histological organ rejection compared to Prograf(R) alone.
Both MEDI-507 and BTI-322 bind specifically to the CD2 antigen receptor found on T cells and natural killer (NK) cells.
5,817,311 relating to the companies' antibodies BTI-322 and MEDI-507, the humanized form of BTI-322.
Previous in vitro studies suggest that BTI-322 and MEDI-507 have the ability to selectively inhibit the response of T cells directed at transplant antigens while subsequently allowing immune cells to respond normally to other antigens.
Nasdaq: MEDI) reported today data from a 20-patient, Phase II clinical trial evaluating BTI-322 for treatment of acute, graft-versus-host disease (GvHD) in bone marrow transplant patients unresponsive to steroid therapy.
We are pleased that the safety results are consistent with our clinical evaluation of BTI-322," commented Elliott Lebowitz, President and Chief Executive Officer of BioTransplant.