Medical Ultrasound Imaging
Thursday, 21 November 2024
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[This entry is marked for removal.] From Acusphere Inc AI-700 (trade name Imagify™) is an US contrast agent, usable for myocardial perfusion undergoing regulatory FDA approval. The synthetic polymers used in AI-700 (perflubutane polymer microspheres) do not break during the ultrasound imaging procedure. The used perfluorocarbon filling gas is less soluble in water and therefore has the propensity to stay inside the contrast agent particles. As a result, a higher concentration of gas is delivered to the myocardium over a longer period of time, thereby enabling AI-700 to target the broader application of myocardial perfusion assessment. Imagify is a dry powder consisting of small, porous microparticles filled with perfluoropropane. These microparticles are made of a synthetic biodegradable polymer, called poly (D, L-lactide co-glycolide), or PLGA, that has been used in other drug delivery systems approved by the FDA. The composition and structure of the phospholipid containing microparticles and the properties of the perfluorocarbon gas slow the rate at which the gas dissolves and prevent the microparticles from being quickly broken down. The powder is to suspend in sterile water and injected by a single intravenous injection prior to ultrasound imaging. In 2009, Acusphere Inc received feedback from the Food and Drug Administration (FDA) to their New Drug Application (NDA) stating that another clinical trial would be required for U.S. approval, this one demonstrating that Imagify with ultrasound is superior to ultrasound without Imagify. In June 2004, Acusphere entered into a Collaboration, License and Supply Agreement with Nycomed Danmark APS for the European development and marketing rights to Acusphere's lead product candidate AI-700. Acusphere's focus will be on preparing the Marketing Authorization Application (MAA) for filing in Q4 2010, building upon the work that the previous partner, Nycomed, had done, in concert with the NDA. In 2008 the FDA panel rejected the regulatory application for AI-700 (Imagify™) because of safety concerns.  Further Reading: News & More:
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Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.
Years
Test Population
Purpose
Success Rate
Preclinical Testing
3.5
Laboratory and animal studies
Assess safety and biological activity
5,000 compounds evaluated
Phase II
2
100 to 300 patient volunteers
Evaluate effectiveness, look for side effects
Phase III
3
1000 to 3000 patient volunteers
Verify effectiveness, monitor adverse reactions from long-term use
12 Total
By Dale E. Wierenga, Ph.D. and C. Robert Eaton Office of Research and Development Pharmaceutical Manufacturers Association 'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.' See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency. •
See also Imagent®. June 19, 2003 Alliance Pharmaceutical Corporation and Photogen Technologies, Inc. announced that they have closed the previously announced transaction whereby Photogen has acquired all of the assets of Alliance related to medical imaging, including all manufacturing and marketing rights to Imagent (formerly Imavist). Terms of the transaction were not disclosed. June 03, 2002 Alliance Pharmaceutical Corp. announced that its ultrasound imaging agent, Imagent (perflexane lipid microspheres), has been approved for marketing by the U.S. Food and Drug Administration. The product will be marketed by Alliance in partnership with Cardinal Health, Inc., a provider of products and services to the healthcare industry, and inChord Communications, Inc., an independent healthcare communications company. March 01, 2002 'Alliance Pharmaceutical Corp. announced that it has entered into a partnership with Bayer Schering Pharma AG, Germany and Cardinal Health Inc. for the marketing of Imavist (perflexane lipid microspheres), an ultrasound contrast agent. Schering licensed worldwide marketing rights for Imavist from Alliance in September 1997. The companies have agreed to modify this agreement to allow Alliance to increase its participation in the marketing of the product. Under the terms of the modified agreement, Alliance will have exclusive marketing rights to Imavist for cardiology indications in the U.S. for five years, and Schering will receive a royalty on product sales. Schering retains marketing rights for other indications in the U.S. and all indications in the rest of the world, subject to Alliance's option to obtain additional indications and territories. Under certain circumstances, Schering would co-market the product at the end of five years. Concurrently, Alliance has entered into a five-year exclusive agreement with Cardinal Health Inc., a provider of products and services to the health-care industry, to assist in the marketing of Imavist.' October 08, 2001 'Alliance Pharmaceutical Corp. announced a clinical study to take place at Thomas Jefferson University Hospital, Philadelphia, using Alliance's Imavist (AF0150) contrast agent with ultrasound imaging to improve detection of prostate cancer. The study, which will involve 300 adult men with suspected prostate cancer, is being funded by the U.S. Department of Defense under a competitive grant awarded to Thomas Jefferson University for investigators at Jefferson's Prostate Center. Imavist is being developed jointly by Alliance and Bayer Schering Pharma AG Germany, and is awaiting final approval from the U.S. Food and Drug Administration.' August 21, 2000 Alliance Pharmaceutical Corp. announced that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the FDA has completed its review of the New Drug Application (NDA) for Imagent (AF0150), and found it to be approvable. Imagent, an ultrasound contrast agent, is being developed jointly by Alliance and Bayer Schering Pharma AG, Germany Notes: The manufacturer is pursuing additional radiology indications such as ultrasound imaging of the prostate and liver, and clinical trials are currently being conducted to evaluate Imagent in conjunction with ultrasound imaging for use in the detection of prostate cancer. During the course of its development, the brand name for this product has changed from Imagent to Imavist back to Imagent. Initially reported on by the manufacturer as Imagent and then, between August 2000 and March 2002, as 'Imavist (formerly Imagent).' The manufacturer's 06/03/02 press release announcing FDA approval refers to the product as 'Imagent (formerly Imavist),' and the approval notice and monograph posted at the FDA site refers to the product as Imagent. Jointly developed by Alliance Pharmaceutical Corp and Bayer Schering Pharma AG, (Germany). Source: PR Newswire - 10/10/96, 03/31/98, 10/13/99, 03/13/01, 10/08/01; FDA approvals - 05/31/02; Alliance Pharmaceutical press release - 06/03/02. •
Different stages of testing drugs in humans for example ultrasound contrast agents, from first application in humans through limited and broad clinical tests, to postmarketing studies. Preclinical trials are the testing in animals.
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Phase I: Safety, pharmacokinetics
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Phase II: Dose
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Phase III: Efficacy
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Phase IV: Postmarketing
See also Drug Development and Approval Process USA, Food and Drug Administration, and European Medicines Agency. • The various gas microbubble contrast media are generally safe with low toxicity in humans. The tolerance of these agents is much higher than that of most x-ray agents, a reflection perhaps of the higher expectation of safety and convenience for ultrasound. Extensive preclinical and clinical trials have demonstrated an excellent ultrasound contrast agent safety profile, the main side effect being a mild and transient local discomfort at the injection site which results from the high osmolality of these agents. Each contrast agent has its own profile of adverse effects, but all have been trivial thus far. See also Ultrasonic Contrast Agents. Further Reading: News & More:
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