AFO 150: Imagent, Imavist

April 2002
Drugs in R&D;2002, Vol. 3 Issue 2, p116
Academic Journal
Adis Comments AFO 150 [Imavist™] consists of perfluorochemical-based microbubbles and is being developed by Alliance Pharmaceutical Corporation in the USA. AFO 150 is an ultrasound contrast agent with use in cardiac function and perfusion, and as an enhancer of the images of prostate, liver, kidney and other organs. In October 1999, Alliance Pharmaceutical submitted an NDA to the US FDA for approval of Imavist™ (formerly Imagent) in the USA. The NDA included clinical data from two phase III trials with Imavist™ that successfully demonstrated a clinically and statistically significant improvement in visualisation of the endocardial border delineation compared with non-contrasted ultrasound imaging. In August 2000, the FDA issued an ‘approvable letter’ for Imavist™. In August 2001, Alliance Pharmaceutical Corporation announced that it had submitted documentation to the FDA addressing issues raised in the ‘approvable’ letter issued a year earlier. As a result of successful pre-approval inspection of its manufacturing facility Alliance Pharmaceutical has received a recommendation for approval of Imavist™ for use as a contrast agent in echocardiography. Alliance Pharmaceutical intends to expand use of Imavist™ beyond cardiac imaging, and is currently investigating the possibility of use of Imavist™ in ultrasound imaging of the prostate and liver. A clinical study with Imavist™ in detection of prostate cancer in 300 men with suspected prostate cancer is currently underway at the Thomas Jefferson University Prostate Center in Philadelphia. It is funded by the US Department of Defence. Imavist™ is being jointly developed by Alliance Pharmaceutical Corporation and Schering AG, a licensee worldwide, and marketed exclusively by Schering AG. Schering AG is preparing to submit a Marketing Authorisation Application for approval of Imavist™ in Europe in 2001. A landmark clinical study in 300 men with suspected prostate cancer is being initiated at Thomas Jefferson University Hospital, Philadelphia, using Imavist™ as a contrast enhancer for ultrasound imaging of prostate cancer. The study is funded by the US Department of Defence under a grant to the University’s Prostate Center. In this non-randomised study all patients will receive an intravenous infusion of Imavist™ followed by transrectal ultrasound imaging and a sextant biopsy. Pre- and post-infusion results will be compared. The per-cancer cost of tumour detection using ultrasound imaging will be compared with currently used digital rectal examination and serum PSA levels test. The principal investigator of the study, Ethan Halpern, MD, Associate Professor, Department of Radiology at Jefferson Medical College, participated in four smaller studies using various ultrasound contrast agents for prostate imaging. In a clinical study in 26 patients with suspected prostate cancer, Imavist™ provided a consistent, superior gray-scale enhancement and promising preliminary results. Along with the improvement in endocardial border delineation indication, Imavist™ is being investigated for use with harmonic ultrasound imaging technique for the enhancement of myocardial perfusion, identification of tumours and other cell masses, and visualisation of blood flow deficiencies. Harmonic ultrasound works in synergy with microbubble-based agents like Imavist™ to provide more precise imaging than that obtained with standard ultrasound. Both companies decided to rename Imagent to Imavist™ in order to correspond with Schering’s family of contrast agents such as Echovist and Levovist. Alliance and Schering are designing studies for Imavist™ to be used in applications such as visualisation of myocardial perfusion and general sonography, and the ultrasound imaging of the liver and other organs. The product is shipped and stored as a powder of hollow, microscopic spheres in a vial containing a perfluorohexane vapor and physiological gas. Prior to use, Imavist™ is mixed with water to form microbubbles that are injected into a patient undergoing ultrasound examination. FluoroMed is manufacturing perflexane (tetradecafluorohexane), a component of Imavist™. Recently, the US PTO has issued a favourable decision to Alliance stating that patent claims by Nycomed Imaging related to microbubbles containing perfluorohexane are invalid, and as a result are unpatentable.


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