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Posted On: 09/09/2020 8:49:27 AM
Post# of 72
SUMMARY COMMENTARY
? Generx [Ad5FGF-4] will initially be focused on refractory angina, which represents a significant
potentially unmet medical need for ~1.2 million U.S. patients with coronary artery disease, representing
a potential addressable market of > $3.0 billion. We believe FDA approval of Generx would be high
profile and garner significant worldwide interest.
? In vitro studies identify FGF-4 as a key biologic regulatory protein that orchestrates the angiogenic
growth factor (e.g. VEGF)- mediated cascade of events required for therapeutic angiogenesis.
? Preclinical studies confirmed and optimized Generx’s receptor-mediated uptake and level of transgene
expression in the heart, and demonstrated an angiogenic mechanism of action (echocardiography).
? Human clinical studies confirmed Generx’s angiogenic mechanism of action, demonstrated increased
cardiac perfusion following a one-time treatment (SPECT imaging), and improvements in exercise
treadmill testing (ETT).
? The FDA-approved Phase 3 AFFIRM study is designed statistically, based on prior Generx clinical study
data, to meet or exceed ETT outcomes that formed the basis for FDA approval of Ranexa.
? Generx angiogenic therapy fits within the current standards of care (administered during a standard
angiography procedure), requires no special devices or training, and will be modestly priced to
maximize market adoption (aligned with stent pricing at $2k to $5k).
? Novel anti-anginal therapies are few and far between. There has been only one anti-anginal drug with a
novel mechanism of action approved by the FDA in the past half-century (Gilead’s Ranexa), which was
acquired one year following FDA approval for $1.4 billion.
? With FDA approval, Generx would be the first Gene Therapy for the treatment of “otherwise healthy
cardiac patients”, that would bring the field into mainstream cardiovascular medicine – an historic
achievement.
? Generx [Ad5FGF-4] will initially be focused on refractory angina, which represents a significant
potentially unmet medical need for ~1.2 million U.S. patients with coronary artery disease, representing
a potential addressable market of > $3.0 billion. We believe FDA approval of Generx would be high
profile and garner significant worldwide interest.
? In vitro studies identify FGF-4 as a key biologic regulatory protein that orchestrates the angiogenic
growth factor (e.g. VEGF)- mediated cascade of events required for therapeutic angiogenesis.
? Preclinical studies confirmed and optimized Generx’s receptor-mediated uptake and level of transgene
expression in the heart, and demonstrated an angiogenic mechanism of action (echocardiography).
? Human clinical studies confirmed Generx’s angiogenic mechanism of action, demonstrated increased
cardiac perfusion following a one-time treatment (SPECT imaging), and improvements in exercise
treadmill testing (ETT).
? The FDA-approved Phase 3 AFFIRM study is designed statistically, based on prior Generx clinical study
data, to meet or exceed ETT outcomes that formed the basis for FDA approval of Ranexa.
? Generx angiogenic therapy fits within the current standards of care (administered during a standard
angiography procedure), requires no special devices or training, and will be modestly priced to
maximize market adoption (aligned with stent pricing at $2k to $5k).
? Novel anti-anginal therapies are few and far between. There has been only one anti-anginal drug with a
novel mechanism of action approved by the FDA in the past half-century (Gilead’s Ranexa), which was
acquired one year following FDA approval for $1.4 billion.
? With FDA approval, Generx would be the first Gene Therapy for the treatment of “otherwise healthy
cardiac patients”, that would bring the field into mainstream cardiovascular medicine – an historic
achievement.
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