Glossary

Acute Administration: "Acute" is a measure of the time scale of a treatment and is in contrast to "subacute" and "chronic. Acute generally means a period of treatment of less than a week. "Subacute" indicates a longer duration of treatment, whilst "Chronic" indicates indefinite duration or treatment.

Acute Injury: The sudden onset of disease or symptoms; for example the onset of a stroke.

Agonist: A drug that mimics the action of a naturally occurring substance.

Alzheimer's Disease: A progressive neurodegenerative disease characterized by loss of function and death of nerve cells in several areas of the brain leading to loss of cognitive function such as memory and language. The cause of nerve cell death is unknown. Alzheimer's disease is the most common cause of dementia.

Antagonist: A drug or compound that partially or completely blocks the effect of another drug or naturally occurring compound such as a hormone.

Anti-apoptotic agent: A compound that blocks apoptosis.

Anti-coagulant: A chemical which prevents blood from clotting.

Anti-inflammatory agent: A substance which directly reduces the inflammatory response of tissue.

Anti-oxidant: A chemical which prevents the abnormal oxidization of compounds by free radicals released from cells in the body. The anti-oxidant, by reacting with the oxidant, protects cells from being damaged.

Apoptosis: A type of regulated cell death in which the cell uses specialized cellular machinery to kill itself. The cell suicide mechanism enables the body to control cell number and eliminate cells that threaten an individual's survival. Also called programmed cell death.

Apoptotic Cascade: A normal regulated series of sequential events in a cell that leads to its death by apoptosis.

Astrocytes: A type of glial cell in the brain that helps support the neurons.

Axons: Processes of nerve cells (neurons) along which the electrical signal flows to the next nerve cell.

Bioavailability: The degree to which a drug or other substance becomes available to the target tissue after administration.

Bioinformatics: The organization and use of biological information, particularly computer- driven processing and analysis of data and databases in the fields of molecular biology and genetics.

Biopharmaceutical: A drug derived by a genetic engineering process or by any other biotechnological means.

Blood Brain Barrier: The barrier system separating the blood from the tissue of the central nervous system. Its anatomical component consists of the cells lining blood vessels having especially tight junctions, which limits the movement of substances in the bloodstream into the brain.

Central Nervous System (CNS): The brain and spinal cord.

Chemoattractive: Any substance that promotes the migration of brain cells, including neurons, in the brain during development or after damage.

Choline Acetyl Transferase (ChAT): An enzyme involved in the production of acetylcholine, which is important in the processing of memory. Reduced activity of ChAT is associated with mild cognitive impairment and Alzheimer’s disease.

Chronic Disease: A disease lasting for a long period of time.

Clinical Trial: Research conducted with volunteer patients, usually to evaluate a new treatment, under strictly controlled conditions. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease.

Cognitive Impairment: A deficiency in the ability to think, perceive, reason or remember resulting in loss of the ability to take care of one's daily living needs.

Contusion: An injury to a part of the body without a break in the skin and leading to a subcutaneous haemorrhage.

Coronary Artery Bypass Graft (CABG) surgery: A surgical procedure which involves replacing diseased (narrowed) coronary arteries with veins obtained from the patient's lower extremities. During this procedure the patient is placed on a heart bypass machine (heart- lung machine) to allow the surgeon adequate time to perform surgery on the resting (non- beating) heart.

Current Good Manufacturing Practice (cGMP): The regulated manufacturing procedures required to ensure quality and purity of a drug compound during production.

Cytokines: Proteins secreted by cells of the immune system that affect other cells in the immune system.

Devic's Disease: A disease causing demyelination of the optic nerve and sometimes the spinal cord. Also called optic neuroencephalomyelopathy.

Diketopiperazines (DKPs): A family of small cyclic neuroprotective compounds being developed by Neuren.

Efficacy: To produce the desired effect.

Encephalomyelitis: Inflammation of the brain and spinal cord.

Endarterectomy: Surgical removal of the inner lining of an artery that is clogged with atherosclerosis.

Endocrinology: The branch of medicine dealing with the endocrine glands and their hormone secretions.

FDA: Food and Drug Administration, the regulatory body in the USA that approves the marketing of new drugs.

Formulation: The drug substance comprising the active drug product and inert inactive ingredients.

Glial cells: The cells in the brain which do not generate electrical signals. There are three main types of glial cell; the oligodendrocyte, microglia and astrocyte. Oligodendrocytes are the source of myelin, the substance surrounding axons that makes electrical conduction efficient. Astrocytes provide the support to the neurons. Microglia are the brains resident immune cells.

Glutamic Acid Decarboxylase (GAD): An enzyme involved in the synthesis of gamma amino butyric acid (GABA).

Glypromate: Neuren's lead drug candidate derived from the three amino acids Glycine- Proline-Glutamate.

Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Good Laboratory Practice

(GLP): A set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

GPE: Original abbreviation used for Glypromate derived from the standard single letter abbreviation for the amino acids Glycine (G), Proline (P) and Glutamate (E).

Grey Matter: Regions of the brain tissue with many nerve cell bodies and few myelinated axons.

Growth Factors: A protein that is involved in promoting cell differentiation and growth.

Growth Hormone: A hormone produced by the anterior pituitary gland that promotes growth and regulates metabolism in the body.

Huntington's Disease: An inherited neurodegenerative condition characterized by abnormal body movements, dementia and psychiatric problems.

Hyperphagia: Increased food intake due to excessive unsuppressible appetite

Hypoxic-Ischemic Injury: An injury caused by lack of oxygen and/or blood supply to an organ.

Immunomodulation: Regulation of the immune response.

In Vitro: Within a test tube or outside a living organism or cell.

In Vivo: Within a living organism or cell.

IND: Investigational New Drug. Before beginning tests (clinical trials) of a new drug on humans, a drug sponsor must submit an IND application to the FDA. The IND contains the plan for the study and must give a complete picture of the drug, including its structural formula, animal test results, and manufacturing information.

Insulin Resistance Syndrome: Failure of insulin to function normally, a condition that often leads to non-insulin-dependent diabetes in which normal levels of insulin in the blood do not produce the normal biological response because of defects in the ability of the tissues to respond.

Insulin-like Growth Factor-1 (IGF1): A 71 amino acid peptide growth factor that is produced in many tissues, especially the liver. It mediates some of the actions of growth hormone.