Glossary

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A

Apolipoprotein the protein combined with a lipid to form a
lipoprotein, a component of HDL and LDL.

ApoA-I is the apolipoprotein component of the HDL particle.

ApoB is the apolipoprotein component of the LDL particle.

ApoA-IMilano a naturally occurring variant of ApoA-I, discovered
in the body of some people from Limone-sul-Garda, Italy.

Atherosclerosis a disease in which the deposition of lipids and
plaque in arteries results in the hardening and decrease of arterial
lumen size.

Atherosclerotic Plaque the deposit or accumulation of lipid containing
plaques in the arterial wall (also known as atheroma).

B

Biomaterial a natural or synthetic material that is suitable for
introduction into living tissue especially as part of a medical
device.

C

Cancer a disease characterized by abnormal and uncontrolled
cell growth.

Cardiovascular Disease (CVD)
is a group of diseases of the heart
and blood vessels.

Cholesterol a fatty molecule essential for normal body functions,
including the production of hormones and bile acids; it is also an
important component of a cell membrane.

Compound a chemical substance formed from two or more
elements (also see drug).

Clinical Trial/Study a research study in human subjects to
evaluate a new drug, medical device, biologic or other
intervention under a strictly controlled scientific setting.
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D

Drug is any substance that can be used to modify a chemical
process or processes in the body to mitigate, treat or prevent a
medical condition.

Drug Eluting Stent (DES) a cylindrical medical device, typically
made of bare metal or a polymer, which is inserted into a body
duct or tube, such as an artery, to prevent collapse.

Dyslipidemia a disorder associated with abnormal levels of blood
lipids and lipoproteins.
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E

Extracellular Matrix (ECM) the space surrounding a cell
containing biochemical molecules, such as proteins and/or
sugars providing a structural element in tissues.
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F

Food and Drug Administration (FDA) is the United States
governmental agency responsible for the approval, manufacture,
usage and sale of food, human diagnostics and therapeutic
products.

Fibrosis the development of fibrous tissue in an organ.

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H

hApoA-I human ApoA-I (see “ApoA-I”).

HepG2 a human cell line derived from the liver or hepatocytes
(liver cells).

High-density Lipoprotein (HDL) a complex of lipids and proteins
(ApoA-I) that function in the transport of cholesterol away from
the tissues to the liver and is associated with a decreased risk of
atherosclerosis and coronary heart disease (also known as “good
cholesterol”)
.

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I

in vitro an experimental procedure conducted artificially, such as
in a test tube or culture media.

in vivo
an experimental procedure conducted in a living
organism.

Investigational New Drug (IND) the application submitted to the
FDA prior to being tested in humans in clinical trials.
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L

Low-density Lipoprotein (LDL) a complex of lipids and proteins
(ApoB) that function by transporting cholesterol to the tissues, in
particular the arteries, and is associated with an increased risk of
atherosclerosis and coronary heart disease (also know as “bad
cholesterol”)
.

Lipids are fatty substances, including cholesterol and
triglycerides that are present in cell membranes and body tissues.

Lipoproteins a complex of proteins and lipids that are the
principle means by which fat and cholesterol is transported in the
blood; major lipoproteins are LDL and HDL.
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M

Macrophage a type of white blood cell that ingests foreign
particles, including cholesterol.

Medical Device a diagnostic or therapeutic article that does not
work by chemical action (see DES).

Messenger RNA (mRNA) a form of RNA that carries the genetic
code for a particular protein from the DNA in the cell’s nucleus to
a ribosome in the cytoplasm and acts as a template for the
formation of that protein.

Monocyte a white blood cell that circulates in the blood and
becomes a macrophage when it enters the body’s tissues and
organs.
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P

Pharmacokinetics the study of how a drug is absorbed,
distributed, metabolized and eliminated (ADME) by the body
over time.

Pharmacological Agent (see “Drug”).

Phase I Clinical Trial a smaller scale trial, where a drug is first
tested on a small number of healthy human volunteers to
evaluate the drug’s safety, schedule, dose, pharmacokinetics and
pharmacodynamics (an approximate 1-2 year time trial).

Phase II Clinical Trial a study intended to evaluate the efficacy of
a new drug in patients suffering from the condition that the drug
is intended to treat (an approximate 1-3 year time trial).

Phase III Clinical Trial a pivotal, large scale study conducted to
demonstrate the safety and efficacy of a new drug in a random
population of patients suffering from the condition that the drug
is intended to treat (an approximate 2-5 year time trial).

Preclinical Studies the studies conducted in animals to evaluate
the toxic effects, pharmacokinetics and metabolism of a drug to
provide evidence for safety, efficacy and bioavailability of the
drug prior to its administration to humans in clinical studies.
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R

Recombinant pro ApoA-I (rproApoA-I) is the recombinant
version of the original secreted form of ApoA-I.

Restenosis the re-narrowing of the inside of a vessel, typically a
complication after an angioplasty.
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T

Therapeutic a biopharmaceutical useful for treating a disease.