Glossary
Adjuvant - A substance which, administered with a drug or antigen, is designed to enhance the degree to which a substance elicits an immune response (antigenicity).
AIT™ Platform Anti-idiotype Induction Therapy (AIT™) enhances the human immune system’s ability to produce a highly specific and effective anti-tumour response.
Alpha Fetal Protein (AFP) - Serum tumor market for identifying tumours most commonly found found in the liver or testes but also for tumours found in the gastro-intestinal tract, genitals, urinary tract, pancreas and ovaries. In is normally found in neonatal humans and disappears as a person matures. It is not normally found in adults.
Antibody - A protein on the surface of B cells that is secreted into the blood or lymph in response to an antigenic stimulus, such as a bacterium or virus, and that neutralized the antigen by binding specifically to it.
Antigens - Any foreign or perceived foreign protein that when entering the body’s chemistry stimulates the production of an antibody.
Anti-CA125 - An antibody or protein molecule that recognizes the ovarian cancer associated antigen known as CA 125.
Antigen - A substance that when introduced into the body stimulates the production of an antibody. Antigens include toxins, bacteria, foreign blood cells, and the cells of transplanted organs.
Antigenicity - The degree to which a substance elicits an immune response.
Antigen Presenting Cells - Antigen presenting cells (APCs) "present" antigen to the body's immune system.
Anti-MUC-1 - An antibody or protein molecule that recognizes the cancer associated mucinous antigen known as MUC-1.
Ascites-Derive Material - Obtained from the fluid of the abdominal cavity of mice that have been implanted with cells that secrete the desired substance.
B-Cell - A type of white blood cell. Many B cells mature into plasma cells, which can produce antibody proteins necessary to fight foreign substances.
BRMs or Cytokines - A group of proteins made by the human body that alter the immune response to enhance, direct or restore the body’s ability to fight disease. BRMs include colony stimulating factors, erythropoietins, interferons, interleukins, and tumor necrosis factor inhibitors.
CA 125 - An antigen that is self produced and is highly associated with ovarian cancer.
CA19.9 - An antigen that is highly associated with gastrointestinal cancers, including pancreatic cancer.
Carcinoma - Any cancerous tumor that starts with the cells that cover the inner and outer body surfaces.
Cell Culture Derived Material - Obtained from the secretion of cells grown in artificial media, often in flasks or tanks.
Cellular Response - An immune system response mediated by antigen specific immune cells, often cytotoxic cells such as T- cells.
cGMP- Current Good Manufacturing Practices - Government promulgated guidelines governing the manufacture of human and animal drugs and biologicals.
Chimeric - Derived from two different animal species.
Chemotherapy or Chemotherapeutic - Generally, the use of chemical agents in the treatment of disease. Specifically the use of cytotoxic drugs to treat cancer.
Chimeric Molecule (Chimigen™) - A combination of an antigen and a xenotypic gragment of an IgG molecule combined recombinantly. -
Clinical Trials - The investigational use of a new drug in humans: Phase I clinical trials test a drug for safety, Phase II clinical trials test a drug for efficacy and safety in a relatively small sample of patients, and Phase III clinical trials test the drug for efficacy in larger numbers of patients and compares the drug with conventional therapies.
Cytotoxic Antibody - Any specific antibody directed against cellular antigens, which when bound to the antigen, activates killer (cytotoxic) cells, resulting in cell lysis (destruction).
Cytotoxic T-Cells - Immune system cells capable of killing other cells.
Double-Blind Placebo-Controlled or DBPC trial - Neither the patient nor the physician is aware of which treatment (placebo or active drug) the patient is receiving.
Efficacy - The ability of a drug to produce desired clinical results.
Epitope - Specific region on an antigen which is recognized by a specific antibody or T-cell.
European Medicines Evaluation Agency or EMEA - The agency responsible for drug product approval in the European Economic Community.
First line chemotherapy - The administration of one or more of a combination of chemotherapeutic agent usually consisting of platinum-based drug and paclitaxel.
HAMA or Human Anti-Mouse Antibody - Human Anti-Mouse Antibody is a human antibody produced in reaction to the presence of foreign (or mouse) antibody.
Health Protection Branch or HPB - The government department responsible for supervising the drug development and approval process in Canada.
Hematological Malignancy - A cancer with its origins in the blood or blood forming tissues, e.g. multiple myeloma.
Humoral Response - An immune system response mediated by antibodies in the blood.
Hybridoma Cells - Any continuously growing cell line generated by the fusion of a myeloma cell and a normal cell and capable of producing antibodies.
Immune System - The totality of organs and cells involved in the body's immunological response to foreign antigens and malignant tissue.
Immunogenicity - The degree to which an antigen is capable of eliciting an immune response.
Immunotherapy - A therapeutic approach to treat diseases by stimulating or enhancing the immune response against the disease.
In vitro - Studies or phenomenon which take place outside the body.
In vivo - Studies or phenomenon which takes place in the body.
Macrophage - A large scavenger white blood cell that engulfs and digests invading micro-organisms and cell debris, also participates in many complex immunological processes.
Malignant/malignancy - Describes a tumor that is cancerous. Two important qualities of malignancies are the tendency to invade surrounding tissues and to break off and spread elsewhere in an organism.
Monoclonal - Derived from a single cell; pertaining to a single clone.
Monoclonal Antibodies or MAb - An antibody that recognizes only one type of antigen. These antibodies are produced by the hybridoma cell.
MUC¬1 - A mucinous antigen that is highly associated with breast cancer and multiple myeloma.
Multi-epitopic Response - Some antigens, e.g. tumor-associated antigens such as ovarian cancer or breast cancer antigens, have multiple antibody binding sites. These antigens are called "multi-epitopic" antigens. A mulit-epitopic response is when an immune response is generated to these multiple epitopes on the antigen.
Myeloma Cell - An immortal reproducing tumor cell originating or derived from the bone marrow.
Nanoparticle Delivery System (related to ViRexx technology) - Biodegradable particles suitable for delivery of therapeutic agents and their size is measured in nanometres.
New Drug Submission or NDA - A document submitted to the FDA or other regulatory bodies containing all the pre-clinical and clinical data collected on a drug to obtain approval for marketing.
New Drug Submission - A document submitted to HPB which is the Canadian counterpart to NDA.
Open Label Trial - Both patient and physician are aware of which treatment the patient is receiving.
Phase IIb - Well controlled trials to evaluate efficacy (and safety) in patients with the disease or condition to be treated, diagnosed or prevented. Sometimes referred to as pivotal trials.
Platelet - An irregular, disc-shaped element in the blood that assists in blood clotting. During normal blood clotting, the platelets clump together (aggregate). Although platelets are often classed as blood cells, they are actually fragments of large bone marrow cells called megakaryocytes.
Potentially Pivotal - A term used to describe clinical trials that would form the basis for a regulatory submission seeking marketing approval for regulatory authorities if the statistical goals of the trial are met.
Pre-clinical Testing - Testing that is conducted in the laboratory and with animals to help determine a product's chemical, pharmacological and pharmaceutical characteristics, toxicity, efficacy, and side effects.
Primary Endpoint - The primary clinical outcome which forms the a priori> basis of statistical hypothesis (including sample size estimation) of a well controlled clinical trial. A fully successful study confirms a treatment of the magnitude sufficient to provide a statistically significant demonstration of the "primary endpoint" for regulatory approval of a product.
Protein - Composed of one or more chains of amino acids. Proteins are fundamental components of all living cells and include many substances, such as enzymes, hormones, and antibodies that are necessary for the proper functioning of an organism.
PSA - An antigen that is highly associated with prostate cancer.
Randomized - Statistical method for even distribution without selection bias.
Secondary Endpoint - Secondary clinical or biological outcomes that can be assessed in analysis of a clinical trial. Although supportive and potentially important, these endpoints are not the a priori primary experimental question proposed for a clinical protocol.
TAG 72 - An antigen that is associated with ovarian cancer and various gastrointestinal cancers.
T-Cell - A form of immune cell that mediates humoral and cellular immune responses.
Thrombus Formation Component (TFC) - Molecule or portion of a molecule that induces a blood clot.
Toxicity - A condition that results from exposure to a substance at levels causing deleterious side effects that may be harmful to an organism.
TPP - Therapeutic Product Programme of Health Canada.
Transaminase - Enzyme produced by the liver and used to measure the degree of inflammation in the liver.
Tumor - An abnormal swelling or lump in a body caused by the growth of new tissues that differ in structure from the part of the body in which they are growing. A tumor may be benign or malignant.
Tumor Necrosis - Tumor deterioration and death.
Tumor Antigen or Tumor Associated Antigen or TAA - An antigen that is predominantly expressed in tumor tissues.
United States Food and Drug Administration or FDA - The regulatory body that oversees the drug development and approval process in the United States.
Von Willebrand factor (VWF) - Large protein found in the bloodstream involved in capturing platelets or binding to platelets to form a blood clot.