Molecular Biosystems Inc.'s second-generation product forultrasound examinations of the heart performed better than thecompany's already approved agent, Albunex, in Phase III trials.
The developmental product, FS069, was tested against Albunex in astudy involving 203 patients scheduled for echocardiography.Patients were required to have at least 33 percent of their leftventricular borders not visible on the baseline echocardiogram.Albunex and FS069 were tested for their ability to provide leftventricular opacification and improvement in endocardial borderdelineation (EBD).
EBD improvement in the FS069 group was 90 percent vs. 59 percentfor the Albunex group (p=.00001). Complete left ventricular chamberfilling was seen in 90 percent of FS069 patients compared to 37percent in the Albunex group (p=.0001).
The results with FS069 were achieved with a much lower dose thanused in other imaging agents, and the safety profile was superior toAlbunex, with an adverse reaction incidence rate of 7 percent.
The agent also was beneficial in enhancing spectral pulsed waveDoppler signal, and the product showed it could help avoid additionaltests in certain patients. In 90 percent of patients investigators wereable to perform the full echo exam, with more than four minutes ofuseful contrast effect achieved.
"FS069 sets the gold standard for efficacy and safety for this nextgeneration of contrast imaging agents," said Kenneth Wilder,Molecular Biosystems' chairman and CEO.
Molecular Biosystems, of San Diego, has an agreement with theMallinckrodt Group Inc., of St. Louis, for marketing of both Albunexand FS069 in the U.S. and much of the rest of the world. Albunexwas approved in August 1994 and launched in October 1994.
The company plans to file for U.S. marketing approval later this year,followed by a filing in Europe. n
-- Jim Shrine
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