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HemoZymeÒ
HemoZymeÒ
is classified as a hemoglobin-based oxygen carrier (HBOC) with
antioxidant activities, and has been developed as a second
generation blood substitute for blood loss in surgery and
hemorrhagic shock. SynZyme's registration strategy with the U.S.
Food and Drug Administration is to demonstrate that HemoZymeÒ
reduces the need for blood transfusions in surgical patients. Once
HemoZymeÒ is approved for
surgical use, the Company will seek approval for the additional
indications of trauma and hemorrhagic shock for combat and civilian
uses. HemoZymeÒ, as opposed to
current HBOCs, is: (a) a vasodilator, (b) an antioxidant enzyme
mimetic and (c) an anti-inflammatory agent. Consequently, HemoZymeÒ
can effectively prevent or treat ischemia, reperfusion, and
inflammatory injuries and the post-reperfusion multiple organ
failure that often follows severe hemorrhagic shock and
resuscitation.
Three characteristics
indicate that HemoZyme® has important advantages over
both red blood cells and other HBOCs:
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HemoZyme®
dilates blood vessels. This property suggests that during
resuscitation after severe hemorrhage, HemoZyme® may
enhance blood flow and thereby maximize the circulation of
residual red cells to perfuse and deliver oxygen to tissues.
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HemoZyme®'s antioxidant
enzyme mimetic activity protects itself against auto-oxidation,
leading to increased stability in vivo and decreased release of
toxic heme and iron.
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HemoZyme®
possesses anti-inflammatory activities, which are not provided by
first-generation HBOCs. This enables it to prevent and treat the
oxidative reperfusion injury and the subsequent multiple organ
failure that is common after severe hemorrhage.
As a
result of these advantages, the Company believes that HemoZyme®
will be significantly better than first generation blood substitute
products at reducing morbidity and mortality in trauma.
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