AMD (Age-related Macular Degeneration)
Chronic degenerative malady of the retina, with onset after the age of 50. The principal cause of vision impairment in adults in the industrialised nations.
Antigen
Natural or synthetic macromolecule recognised by the immune system and capable of triggering an immune response.
Autoimmune disease
Disease caused by an inappropriate immune response directed to self antigens of own cells or tissues.
Crohn’s Disease
A chronic inflammatory condition that can affect any part of the digestive tract but is most common in the colon, ileum and anus. The cause of Crohn’s Disease is unknown. Symptoms include diarrhea, abdominal pain, anal or peri-anal fissures, abscesses or fistulas, and abdominal swelling. Systemic symptoms include fever, weight loss and general malaise.
Cytokine
Protein mediating intercellular communication that orchestrates immune and inflammatory responses as well as haematopoiesis. Cytokines are the key players in the regulation of the immune system.
Double blind clinical trial
Prospective comparison between two randomly selected groups, one receiving the treatment under study, the other a placebo or current standard of care treatment, with neither the patient nor the treating doctor knowing which product is being administered.
Epitope
Portion of the antigenic molecule that combines with the specific corresponding antibody.
Haematopoiesis
Physiological process of the creation and renewal of blood cells.
Interferon (IFN)
Protein family that plays an important role in the defence against viruses, bacteria and parasites.
Immunogen
Substance with the ability to induce an immune response.
Kinoid®
Immunogenic compound based on inactivated cytokines whose administration triggers the production of neutralising polyclonal antibodies targeting the cytokines abnormally produced in pathologic tissue.
Monoclonal antibody
Monoclonal antibodies (mAbs) are monospecific immunoglobulins synthetically issued by cloning a unique parent cell. Monoclonal antibodies usually recognise only one epitope on a given antigen.
NDA
New drug approval. Approval for drug commercialisation granted by the competent authority in the country in question. An NDA can granted more quickly as a conditional NDA if the risk/reward ratio for the therapy in question is positive, the drug addresses a serious unmet medical need and the public health benefits are judged superior to the risk linked to uncertainties resulting from an incomplete evaluation of the drug.
Phase 1 Clinical Trial
The first study of an investigational pharmaceutical in human beings, following extensive preclinical research in the laboratory and in animals. Objectives are to determine the safety of the drug, as well as the initial study of pharmacodynamics and pharmacokinetics. Phase 1 studies are typically conducted in health volunteers, but in some cases they may be conducted in patients with the condition the drug is designed to treat, in which case they are referred to as Phase 1/2 studies.
Phase 2 Clinical Trial
A study of an investigational drug in patients with the condition the drug is designed to treat. Phase 2 studies may involve single or multiple doses or differing administration regimes. Phase 2 studies typically have as objectives the safety of the therapy under study, the identification of a dosing regime and initial evidence of clinical efficacy.
Polyclonal antibodies
Polyclonal antibodies are immunoglobulins that are produced by different B cell sources, each identifying a different epitope. Polyclonal antibodies are therefore a combination of antibodies recognising different epitopes on a given antigen.
Proof of concept
Initial clinical results indicative of efficacy.
Polyarthrite Rhumatoïde (PR)
Maladie inflammatoire auto-immune dans laquelle le système immunitaire attaque et détruit progressivement les articulations conduisant à des problèmes majeurs de mobilité et de dextérité.
Psoriasis
Relatively common chronic inflammatory non-contagious autoimmune skin disease.
Rheumatoid arthritis (RA)
Rheumatoid arthritis is an autoimmune inflammatory disease in which the immune system progressively attacks and destroys joint tissues, with a major negative effect on a patient’s dexterity and mobility.
Systemic lupus erythematosus (SLE)
Systemic lupus erythematosus is an autoimmune disease characterized by a loss of immune tolerance, in particular by the B lymphocytes that produce antibodies. Lupus is a multi-organ disease that can cause severe kidney damage leading to kidney failure, as well as damage to the nervous system, the cardio-vascular system and the patient’s joints.
Tumour Necrosis Factor (TNF)
Protein that plays an important role in the defence against bacteria and tumours.
Vascular Endothelial Growth Factor (VEGF)
Protein that plays an important role in the formation of new blood vessels from existing blood vessels.
