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ImaRx Provides Update on TUCSON Phase I/II Clinical Trial in Acute Ischemic Stroke
Date:1/4/2008

TUCSON, Ariz., Jan. 4 /PRNewswire-FirstCall/ -- ImaRx Therapeutics, Inc. (Nasdaq: IMRX) today provided an update on its TUCSON (Transcranial Ultrasound in Clinical SONolysis) clinical trial in patients with acute ischemic stroke.

TUCSON Study Overview

The TUCSON trial is a Phase I/II randomized, placebo controlled clinical trial. This trial is designed to evaluate the safety, tolerability and activity of four escalating doses of MRX-801 microbubbles and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke. The trial design includes four dose cohorts of 18 subjects each randomized to receive either treatment (MRX-801, ultrasound and tPA) or control (tPA alone). Safety is assessed by the incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours following the initiation of treatment. Activity is assessed by recanalization, defined as increased blood flow in the occluded artery, which is viewed by clinicians as a key factor in improving the probability of complete clinical recovery. Improvements in functional and neurological outcomes are measured by improvement in NIHSS and Modified Rankin scores, widely accepted instruments used to assess clinical outcomes for stroke. To date, the Company has completed enrollment of all 18 subjects in Cohort 1 (12 treated and 6 control) and 17 subjects in Cohort 2 (11 treated and 6 control).

TUCSON Preliminary Results

Cohort 1

Cohort 1 evaluated one vial of MRX-801. There were no unexpected safety events and there were signs of improved recanalization in treated patients compared to controls. In clinical recovery endpoints, the number and proportion of patients who experienced dramatic or e
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SOURCE ImaRx Therapeutics, Inc.
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