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
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.
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,
ImaRx Therapeutics, Inc.
Courtney Plotnick, 520-770-1259 ext. 193
Atkins & Associates
Virginia Amann, 608-274-6046