5. data and comments. 5, page-83

re: 5. glossary. 5 Armamentarium Drugs, treatments or resources available.
Bolus A large dose given intravenously so that the desired therapeutic concentration in the blood is reached rapidly.
CDER Centre for Drug Evaluation & Research. A division of the FDA.
cGMP Current good manufacturer practices. These practices are more fine tuned and up to date methodologies and procedures, mandated by regulatory authorities, which are to be followed in testing and manufacturer of pharmaceuticals to ensure manufacture of safe clinical supplies.

DNA The molecule that carries genetic information in all living things; the chemical basis of heredity. Damaged DNA can lead to uncontrolled growth of cells which is commonly known as cancer.

ELISA Enzyme-Linked Immunosorbent Assay. A method of analyzing Melanotan in the blood of clinical trial subjects.
EMEA European Medicines Evaluation Agency. London based agency in Europe began in 1995. Co-ordinates drug licensing and safety through Europe.
Eumelanin The UV-protective dark pigment produced
by melanocytes.
FDA United States’ Food & Drug Administration.

Fitzpatrick Skin Type Classification system based on a
person's sensitivity to sunlight. People with skin types I and II are at the highest risk for photoaging effects including wrinkles and skin cancer.

IND Investigational New Drug. Companies seeking to begin clinical studies of a new pharmaceutical drug are required to lodge this application with the FDA.

Keratinocytes Skin cells that receive melanin from the
melanocytes.
LC/MS/MS Liquid Chromatography/Mass spectrophotometry.
A sophisticated method of analyzing Melanotan in the blood of clinical trial subjects.

MCA Medicines Control Agencies – in concert with Communication
Safety in Medicines regulates the approval safe pharmaceutical products in UK.
Melanin Produced by melanocytes, the amount of which produces skin pigmentation.
Melanocytes The cells in the skin that produce melanin.
Melanogenesis A unique biochemical process whereby melanin is produced in the body.

Melanotan A more potent synthetic copy of the naturally occurring hormone, -MSH. Induces a natural tanning of skin, via melanogenesis, without the harmful effects of UV radiation.
MRA Mutual Recognition Agreement.
-MSH alpha-Melanocyte Stimulating Hormone.
NCE New Clinical Entity.
NDA New Drug Application.
Phaeomelanin The red-yellow non UV-protective pigment produced by melannocytes.

PK Pharmacokinetics - deals with what happens to a substance that is introduced into a living system e.g. how quickly broken down and pathway etc.
Branch of pharmacology dealing with the reaction between drugs or synthetic food ingredients and
living structures.

Phase I The first in a series of human tests of new
pharmaceuticals. The primary purpose of the Phase I clinical test is to detect if the new pharmaceutical is toxic or otherwise harmful to normal, healthy humans. The conclusion of Phase I testing leads to Phase II and Phase III testing.

Phase II The second in a series of human tests of new
pharmaceuticals. The primary purpose of the Phase II clinical tests is to determine the pharmaceutical's efficacy (i.e., does it work?). Successful conclusion of Phase II tests allows Phase III clinical tests to begin.

Phase III The third in a series of human tests of new
pharmaceuticals. The primary purpose of Phase III clinical tests is to increase the number of people exposed to a new pharmaceutical and verify proper dosage.

PMLE/PLE Polymorphic light eruption (PLE), otherwise termed polymorphous light eruption (PMLE), is a skin disorder caused by sunlight. A delayed-onset, spotty, itchy eruption appears on the skin, and may take between 5 to 10 days to clear.

The rash usually consists of small red spots or blisters and can appear on any part of the body that has been exposed to sunshine, although commonly the face and the backs of the hands will be spared. It tends to heal without scarring.

PUVA Treatment involving exposing patients to ultraviolet radiation after they have taken a drug called methoxsalen (8-MOP). The UV light activates the drug, which then binds to DNA and causes cell death.

Restoraderm™ A technology invented by Mr Thomas Sköld to transport molecules through the skin.
Sustained-release A process whereby the drug is released from a formulation over a long period time with only one injection.

Tan: The body’s natural response to protect itself from further skin damage caused by UV radiation.
TGA Therapeutic Goods Administration.
Topical lotion A cream or gel applied to the skin.
UV light / UV radiation Ultraviolet light / Ultraviolet radiation.

Vitiligo Vitiligo (also called "leukoderma") is a skin condition in which there is loss of pigment from areas of the skin resulting in irregular white spots or patches, even though the skin has normal texture. Vitiligo may appear at any age.

Although it is a progressive condition, many people experience years or decades without developing new spots. The cause of vitiligo is not greatly understood, and there may be many causes that result in the condition.

Extracted from the Annual Report.


Gerry