Glossary
Here are some definitions for words and abbreviations we commonly use:
Adjuvant: A pharmacological agent added to a drug to increase or aid its effect
Angiotensin: A protein in the blood that causes vasoconstriction, increased blood pressure, and release of aldosterone from the adrenal cortex
Antibody: Substances produced by cells of the immune system which bind to parts of other molecules in a highly specifi c way and may neutralize their effect
Antidote: A remedy to relieve, prevent, or counteract the effects of a poison
Antigen: A substance that stimulates an immune response
B-cell: A type of lymphocyte (white blood cell)
B-cell Chronic Lymphocytic Leukaemia or (B-CLL): a type of cancer in which B-cells, over accumulate
BLA or Biological License Application: US equivalent of a MAA for a biological product
Caricotamide: A cosubstrate present in Prolarix™
Chromatography: A method of separating a mixture of proteins by passing a fluid containing the mixture over a stationary material, which may be porous
Clinical development: The stage of pharmaceutical research and development where potential drugs are studied in human clinical trials
Compassionate use: The provision of an unapproved drug for the treatment of an individual patient at the specific request of a physician
Cosubstrate: A second or other substrate required by enzymes to carry out a chemical reaction
Crotalid: Any snake of the family Crotalidae, also called pit viper, which includes rattlesnakes
Cytotoxic: A molecule or drug that is toxic to cells
Cytokine: A cellular messenger, typically of the immune system
EDLFs: Endogenous Digoxin-Like Factors
EMEA: European Medicines Agency
Endogenous enzyme: An enzyme that occurs naturally in cells or tissues
Envenomation: The injecting of a poisonous material (venom) via a bite or other means
Ex vivo: A test performed outside the body on a sample taken from a living organism
Fab: Part of an antibody molecule which can be split from the whole molecule and which still retains its binding capability
FDA: US Food and Drug Administration; the government body responsible for regulating pharmaceuticals in the US
HDMTX: High dose methotrexate
Hypertension: Blood pressure that is above medically defined normal limits and which is associated with increased risks of stroke and heart disease
ICU: Intensive care unit
In vitro: A test or technique performed in a controlled environment generally separate from the whole organism
Leucovorin: Leucovorin (also known as folinic acid) is an adjuvant used in cancer treatment to reduce the toxicity of the chemotherapy agent methotrexate or to enhance the cytotoxic (anti-tumour) activity of the chemotherapy agent 5-fl uorouracil
Marketing Authorisation Application (“MAA”): The complete set of data supporting the quality, safety and efficacy of a medicinal product which is submitted to a regulatory agency in order to obtain market approval in the EU
MHRA: Medicines and Healthcare Products Regulatory Agency
MTX or Methotrexate: A cytotoxic agent commonly used in the treatment of certain cancers
Named patient basis: The supply of a medical product for use by specific patients, prior to granting of a MAA, when no other effective treatments are available
Pharmacokinetics: The process by which a drug is absorbed, distributed, metabolised and eliminated from the body
Phase I study: The initial clinical assessment of the safety, pharmacodynamics and/or pharmacokinetics of a drug candidate in human subjects
Phase I/II study: As for Phase I study, but clinical assessment conducted in patients
Phase II study: The clinical assessment in patients of a drug to determine dose range and preliminary efficacy. A phase IIa study is to examine the pharmacological effect of the drug and a phase IIb is to evaluate the appropriate dose for phase III
Phase III study: The clinical assessment of the effi cacy and safety of a drug, usually in comparison with a marketed product or a placebo, in the patient population for which it is intended
Polyclonal antibody: A mixture of antibodies produced in response to a specifi c antigen, that bind to different parts of the antigen
Pre-eclampsia: Hypertension which arises in pregnancy in association with signifi cant protein in the urine and can lead to seizures and death
Prodrug: An inert chemical which can be activated within the body to an active drug
Proof of concept: Studies in animals or man to demonstrate the expected action of the drug
®: A trademark which has been registered in both the United States and an EU member state
Sepsis: A spectrum of disorders caused by the body’s exaggerated response to infection or injury. The defining characteristics are inflammation, abnormal vital signs and failure of one or more major organ systems.
Tretazicar: The cytotoxic prodrug component of Prolarix™
Therapeutic: A product used to treat a disease
TNF-alpha: Tumour necrosis factor alpha, a cytokine, involved in the body’s infl ammatory process
™: An application to register the trademark is pending in either the US or an EU member state
Vaccine: A substance used to stimulate an immune response to raise antibodies against the target substance
Vasoactive substances: Substances that dilate or constrict blood vessels
Top of page