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ImaRx's SonoLysis Enters Phase II Stroke Trial; Study is First to Combine Nanobubbles with Ultrasound for Less Invasive Treatment of Stroke

 

TUCSON, Ariz.--(BUSINESS WIRE)--April 5, 2005--ImaRx Therapeutics, Inc. announced today that the first patient has been treated in a new Phase II clinical trial evaluating the safety and effectiveness of SonoLysis(TM) for the treatment of acute ischemic stroke. SonoLysis, which combines external ultrasound and ImaRx's proprietary nanobubble, is designed to clear blood clots quickly and without the use of invasive surgery or potentially dangerous lytic drugs.


"Our SonoLysis nanobubbles are injected intravenously to accumulate at the site of a blood clot. With the application of ultrasound, the bubbles are designed to pulsate and break apart to physically impact and destroy the clot," said Evan Unger, M.D., President and CEO of ImaRx. "Due to its mechanism of action, SonoLysis is a unique technology that can potentially be used both in stroke centers and in emergency rooms, where most stroke patients first go for treatment. SonoLysis has the potential to clear clots more quickly than the current standard of care, which is important because faster treatment can help minimize the neurological damage and disability caused by strokes."

Aside from aspirin, there are currently only two FDA approved treatments for stroke: the Merci Retriever and t-PA. The Merci Retriever, an invasive corkscrew-like device, is inserted into the artery to extract blood clots from brain arteries in acute ischemic stroke patients. The other approved treatment, a lytic agent known as t-PA, breaks down clots and can be used only within the first three hours following the onset of stroke.

ImaRx's multicenter trial is a 40-patient, randomized and blinded study. Trial results will build on those from an earlier study by Dr. Andrei Alexandrov, Associate Professor of Neurology at the University of Texas at Houston. This study was recently published in the New England Journal of Medicine(1). The Texas trial set out to determine whether ultrasound could safely enhance the clot dissolving ability of t-PA. Results showed that 38% of patients who received ultrasound and t-PA had complete clearance of their clots within two hours of treatment, compared with only 13% of those who received t-PA alone.

Dr. Alexandrov believes that by incorporating ImaRx's nanobubbles into the treatment, results from the Texas trial can be improved. "We may see several benefits to treating ischemic stroke patients with the ImaRx nanobubbles along with ultrasound and t-PA. I expect a greater percentage of patients will have their clots cleared and that less lytic agent will be required to treat blood clots. SonoLysis can also be applied without a lytic drug, which is an enormous benefit since lytics increase the risk of hemorrhage and can only be used within a three-hour time window after the stroke occurs."

Dr. Alexandrov, a recognized thought leader in acute ischemic stroke, is a member of ImaRx's Scientific Advisory Board.

Related research was presented by Dr. Carlos Molina this past February at the International Stroke Conference. Dr. Molina and his colleagues tested t-PA, ultrasound and microbubbles against t-PA and ultrasound in 103 stroke patients. The researchers used an off-label diagnostic bubble and reported that 55% of the t-PA, ultrasound and microbubble group showed complete recanalization (restored bloodflow) at two hours compared to 41% of the t-PA and ultrasound group (p=0.038).

About Stroke

According to the American Stroke Association, stroke is the #1 cause of disability in the U.S. and trails only heart disease and cancer as a leading cause of death. In 2004, stroke directly affected more than 700,000 people and accounted for more than $53 billion in costs to the U.S. health care system. For more information, please visit www.strokeassociation.com.

About ImaRx

ImaRx, a privately-held biopharmaceutical company, develops NanoInvasive(TM) therapies for the treatment of cardiovascular and CNS diseases and cancers. The Company's lead product, SonoLysis(TM), combines the power of ultrasound with proprietary nanobubbles to locally dissolve blood clots without the use of invasive surgery or potentially dangerous lytic drugs. SonoLysis is currently in a Phase II study for stroke and a Phase I/II study for deep vein thrombosis. A Phase I/II study to treat peripheral arterial occlusive disease will commence early this quarter. For more information, please visit www.imarx.com.

1. Alexandrov. A., et al., Ultrasound-Enhanced Systemic Thrombolysis for Acute Ischemic Stroke. The New England Journal of Medicine, 2004; 351:2170-8.

Contacts


ImaRx Therapeutics, Inc.
Courtney Plotnick, 520-770-1259 ext. 193
cplotnick@imarx.com
or
Atkins & Associates
Virginia Amann, 608-274-6046
vamann@irpr.com



This story has been adapted from a news release -
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