Printer Friendly

SONUS PHARMACEUTICALS FILES WITH FDA FOR HUMAN TESTING OF ECHOGEN(TM) INJECTABLE ULTRASOUND CONTRAST AGENT

 SAN FRANCISCO, Jan. 10 /PRNewswire/ -- Sonus Pharmaceuticals announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for permission to begin Phase I human testing of EchoGen(TM), its first injectable ultrasound contrast agent.
 The announcement was made by Steven C. Quay, M.D., Ph.D., company founder, president and chief executive officer, on the first day of the 12th Annual Hambrecht & Quist Life Sciences Conference, which is being held here through Jan. 12.
 According to Quay, the objective of the Phase-I clinical trials will be to determine the safety and tolerance of the EchoGen contrast agent, to measure the pharmacokinetics or clearance rate of the drug and to measure the dose response of image enhancement of the heart and abdominal structures following intravenous administration.
 "This marks a key milestone in Sonus' product development," said Quay. "We are rapidly moving forward in our program to develop an easy- to-administer ultrasound contrast agent that consistently fulfills the physician's need to assess heart-wall motion and to better evaluate regional patterns of blood flow."
 Utilizing Sonus' proprietary PhaseShift(TM) and High Q-factor(TM) Gas technologies, EchoGen is a dodecafluoropentane-based, injectable emulsion that transforms from a liquid into highly echogenic microbubbles upon entering the bloodstream. In a pre-clinical canine study performed under the direction of Dr. Anthony DeMaria, professor of cardiology and chief of clinical cardiology at the University of California at San Diego, persistent myocardial opacification was achieved with the injection of EchoGen into a peripheral vein. In a similar corroborative canine study performed by Dr. Shintaro Beppu and his associates at the National Cardiovascular Center, Research Institute, Osaka, Japan, EchoGen was used successfully to visualize and assess ischemia following experimental blockage of the circumflex artery, which provides oxygenated blood to the myocardium. To support the IND filing, the company has performed over 35 separate non-clinical safety studies.
 The goal for EchoGen's development is to provide cardiologists with a product that improves on the diagnosis of cardiac chamber size, wall motion abnormalities, valvular function and blood flow through heart tissue (myocardial perfusion). These same product capabilities could be used in radiology applications to enhance the grey-scale and doppler analysis of blood flow in the kidneys, liver, breast, prostate and peripheral vessels. EchoGen is the first ultrasound contrast agent to consistently demonstrate in non-clinical studies the enhancement of perfusion images from a peripheral venous administration site. Furthermore, studies have shown that the EchoGen contrast agent does not produce a significant loss of anatomic landmarks, known as attenuation, which can interfere with accurate diagnoses.
 The duration of the Phase I clinical trial is expected to be approximately four months and involves approximately 40 healthy adult volunteers between the ages of 18 and 45. They will receive injections of EchoGen, and their vital signs and other safety parameters will be monitored for safety and tolerance of the agent. Ultrasound examinations will be performed before and after the injections to determine the level of image enhancement of normal cardiac and non- cardiac structures.
 Sonus Pharmaceuticals Inc., of Costa Mesa, Calif., is a privately held medical company founded in 1991 to develop and commercialize novel ultrasound contrast agents for diagnostic applications in echocardiology, general radiology, gynecology and neuroradiology. The company's products hold the promise of improving the diagnosis of heart disease, cancer, infectious diseases and other debilitating medical conditions.
 -0- 1/10/94
 /CONTACT: Tom Gable or Kris Lichter of Gable/Versaggi BioCommunications, 619-234-1300/


CO: Sonus Pharmaceuticals Inc. ST: California IN: MTC SU:

JP-LS -- SD001 -- 0562 01/10/94 12:03 EST
COPYRIGHT 1994 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1994 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 10, 1994
Words:594
Previous Article:PENNSYLVANIA HITS AIRWAYS WITH NEW WINTER TRAVEL AD CAMPAIGN, ISSUES 1994 VISITORS GUIDE
Next Article:STATE WATER HEARING SET IN TRUCKEE
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters