CLINICAL DEVELOPMENT: AWARE CLINICAL STUDY
- Purpose
The Phase 3 AWARE trial will study the
effects of Generx™ (Ad5FGF-4) in women for the potential
treatment of myocardial ischemia (insufficient blood
flow within the heart muscle) which gives rise to angina
associated with coronary heart disease. Generx
is an investigational product designed
to promote angiogenesis, a natural process
of blood vessel growth within the heart
muscle.
- Study Design
AWARE (Angiogenesis in Women with Angina
pectoris who are not candidates for Revascularization)
is a randomized, placebo-controlled,
double-blind safety and efficacy study
to evaluate a one-time intracoronary
administration of Generx. The AWARE study is enrolling
approximately 300 women with recurrent stable angina pectoris
who are not candidates for revascularization and who are
receiving optimal drug therapy. Approximately 50
U.S. medical centers are expected to
participate in the AWARE study.
- Primary
and Secondary Measures
The primary endpoint will be the improvement
in time to onset of electrocardiogram changes
diagnostic of myocardial ischemia during exercise
treadmill testing at six months following administration. The
secondary endpoints will include improvement in myocardial
blood flow within the affected heart muscle measured
by adenosine SPECT (single photon emission computed tomography)
imaging, as well as improvements in other measures
of angina.
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