ImaRx Provides Update on TUCSON Phase I/II Clinical Trial in Acute Ischemic Stroke
January 04 2008 - 7:00AM
PR Newswire (US)
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 early
clinical recovery were higher in the treatment group compared to
controls. Clinical recovery at 24-36 hours was roughly equivalent
in both groups as was neurological improvement at 24-36 hours.
Clinical evaluations at 90 days post-treatment favored the
treatment group. Cohort 2 The second dose cohort evaluated two
vials of MRX-801. Activity data from subjects in this cohort is
currently being collected and will be available in the second
quarter of 2008. From a preliminary evaluation of the safety data
that have been collected to date, there were a greater number of
intracranial hemorrhage events observed in subjects receiving
treatment relative to controls. Upon a review of these data,
consultation with the Data and Safety Monitoring Board and review
by the TUCSON Steering Committee, the Company has elected to
suspend further enrollment in the study and intends to conclude the
study at this stage. According to Garen Manvelian, MD, Chief
Medical Officer for ImaRx, "We are very encouraged by the data from
Cohort 1 and are pleased to have observed activity with the lowest
dose of MRX-801. We have learned what we set out to accomplish
through this clinical trial." Dr Manvelian further stated, "It is
well known that tPA has an associated risk of bleeding. We believe
that the intracranial hemorrhage events, such as those observed in
Cohort 2, may be reduced by eliminating tPA in our future
SonoLysis(TM) clinical studies in stroke." Paul Sierzenski, MD,
North American Principal Investigator for the TUCSON study, stated,
"As an Emergency Physician, I diagnose and treat a significant
number of patients who are victims of stroke. Physicians of all
specialties recognize the devastating impact this disease has on
our patient's lives. ImaRx's SonoLysis therapy employs a
fundamentally unique approach to the treatment of ischemic stroke.
I am excited about the opportunity to participate in future
clinical trials to advance the development of this important stroke
therapy." Future Development Plans The Company intends to initiate
its next SonoLysis clinical study in the second half of 2008. To
avoid the inherent bleeding risk associated with tPA, the Company
intends to conduct its future clinical trials under its SEDONA
program, MRX-801 microbubbles and ultrasound, without tPA. Prior to
commencing the trials, the Company intends to conduct its
previously announced pre- clinical studies designed to further
optimize the ultrasound delivery parameters. "Concluding the TUCSON
study ahead of schedule allows us early access to data and helps us
to reduce our expenses," said Bradford A. Zakes, President and CEO
of ImaRx Therapeutics. "We look forward to the continued
advancement of our SonoLysis technology for stroke under our SEDONA
program." About ImaRx Therapeutics ImaRx Therapeutics is a
biopharmaceutical company developing and commercializing therapies
for vascular disorders. The Company's research and development
efforts are focused on therapies for stroke and other vascular
disorders using its proprietary microbubble technology. ImaRx
Therapeutics' commercialization efforts are currently focused on
its product, urokinase, for the treatment of acute massive
pulmonary embolism. Cautionary Statement For The Purpose Of The
"Safe Harbor" Provisions Of The Private Securities Litigation
Reform Act of 1995 Note: Statements made in this press release
which are not historical in nature constitute forward-looking
statements for purposes of the safe harbor provided by the Private
Securities Litigation Reform Act of 1995. Such statements include
those related to our belief that the intracranial hemorrhage
events, such as those observed in Cohort 2, may be reduced by
eliminating tPA in our future SonoLysis clinical studies in stroke,
our intention to initiate the next SonoLysis clinical study in the
second half of 2008 and our intention to conduct previously
announced pre-clinical studies designed to further optimize the
ultrasound delivery parameters. These statements are based on
management's current expectations and beliefs and are subject to a
number of factors and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. Such risks and uncertainties include: data from our
clinical trials under our SonoLysis program may not be positive or
ultimately support the filing of an NDA; and, we may not have or be
able to secure sufficient capital to fund our operations and the
development and commercialization of our product candidates. All
information in this press release is as of January 4, 2008, and the
Company undertakes no duty to update this information. A more
complete description of these risks can be found in the Company's
filings with the Securities and Exchange Commission. Contacts:
ImaRx Therapeutics, Inc. The Ruth Group Jennifer Marshall Sara
Ephraim (investors) VP Corporate Dev. & Investor Relations
Jason Rando (media) (520) 770-1259 DATASOURCE: ImaRx Therapeutics,
Inc. CONTACT: Jennifer Marshall, VP Corporate Dev. & Investor
Relations of ImaRx Therapeutics, Inc., +1-520-770-1259, ;
Investors: Sara Ephraim, , or Media: Jason Rando, , both of The
Ruth Group, for ImaRx Therapeutics, Inc.
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