TUCSON, Ariz., Sept. 28, 2004 (PRIMEZONE) -- ImaRx Therapeutics, Inc., (www.imarx.com) announces the initiation of its Phase I/II clinical trials in deep vein thrombosis. The study is designed to demonstrate the safety and potential efficacy of SonoLysis, ImaRx's patented technology designed to dissolve blood clots. This multi-site study will enroll 24 patients from academic institutions and private practice centers throughout the United States.
SonoLysis, a unique clot dissolving therapy, uses ultrasound to cavitate gas-filled microbubbles to dissolve clots. ImaRx's proprietary microbubbles are injected near the clot site via catheter or intravenous injection. The ultrasound releases specific pulse sequences activating the microbubbles in the vicinity of the clot for final dissolution.
Dr. Robert McLafferty, a vascular surgeon at the Southern Illinois University School of Medicine and one of the study's principal investigators, states, "SonoLysis holds great promise in the treatment of thrombosis. The existing methods for treating clots have certain side effects that we can potentially avoid with SonoLysis."
ImaRx's Founder and President, Dr. Evan Unger, says, "Given the safety and feasibility data from the Phase I/II dialysis graft trials, we are pleased to be moving ahead with our next indication, deep vein thrombosis."
Phase I/II Study
Phase I/II studies are conducted in the targeted patient population and combines the drug safety testing associated with Phase I studies and the initial efficacy evaluations associated with Phase II studies. Phases I and II are frequently combined to study diseases or conditions that are fatal or debilitating in order to speed the drug development process.
About ImaRx
ImaRx is a privately held biopharmaceutical company developing therapeutic technologies to treat cardiovascular and central nervous systems diseases and cancers. The SonoLysis microbubbles are an optimized version of the microbubbles that ImaRx Pharmaceuticals sold to DuPont in 1999 (subsequently acquired by Bristol-Myers Squibb Medical Imaging, Inc. (www.bmsmi.com). BMS's Definity is now a top selling diagnostic contrast agent. As part of the sales and licensing agreement, ImaRx retained all therapeutic rights to the microbubbles including SonoLysis. Phase II clinical trials for the therapeutic treatment of stroke and Phase I/II for acute limb ischemia are scheduled to begin later this year, while trials in myocardial infarction, vulnerable plaque and blood brain barrier may commence as early as 2005.
Forward-Looking Statement
This release contains forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA, and other regulatory authorities, and the Company's success in raising capital.