Glossary

ActoGeniX: ActoGeniX is a biopharmaceutical company focused on the development and commercialization of a new generation of biological drugs called ActoBiotics™.
ActoBiotics™:  ActoBiotics™ are created using TopAct™ technology and consist of living food‑grade bacteria that are engineered to synthesize and secrete therapeutic proteins or peptides. They are delivered to patients in a natural way, via oral administration rather than by injection, and specifically target receptors and cells localized in the gastrointestinal tract. ActoGeniX believes that ActoBiotics™ represent a paradigm shift in the application of biological molecules for therapeutic treatment.
AG011: AG011, an ActoBiotic™ that secretes human IL-10, is ActoGeniX’s lead product for treatment of inflammatory bowel disease. A Phase 1 clinical trial in Crohn’s disease patients has already provided promising, positive indications and ActoGeniX is now preparing for a Phase 2a clinical study, to be initiated in the course of 2008.
AG013: AG013, an ActoBiotic™ that secretes trefoil factor peptides, is in advanced preclinical development for the treatment of oral mucositis. Initiation of clinical development is scheduled for early 2009.
Allergic asthma:  Allergic asthma is a particular, common type of asthma in which certain types of allergens can trigger asthma attacks and symptoms such as coughing, wheezing, and shortness of breath.
  1. Allergy:
 Allergy is commonly described as an abnormal reaction of the body’s immune system to a foreign substance. Frequently, these substances include pollen, dust mite feces, mold spores, pet dander, specific food components, insect venom or medicines. As symptoms vary, an allergic reaction may result in a runny nose, sneezing and coughing, wheezing, shortness of breath or rapid breathing, itching, rashes, swelling and chest tightness. A severe allergic reaction, anaphylaxis, can be life-threatening.
Anaphylaxis: see IgE.
Analgesic mouthwash:
  1. Mouthwash aimed at alleviating pain.
Antibodies: Antibodies are an essential component of the immune system proteins and identify and neutralize specific molecules and pathogens. Antibodies can prevent these foreign entities from entering or damaging cells and they can stimulate removal and even direct destruction of pathogens.
  1. Autoimmune diseases:
 Autoimmune diseases result from the development of an aberrant immune response against substances and tissues normally present the body, damaging endogenous cells and tissues. Prominent examples include Celiac disease, Type 1 diabetes, multiple sclerosis and rheumatoid arthritis.
  1. Biological drugs:
 Biological drugs (also referred to as biologics or biopharmaceuticals) include a wide range of medicinal products that are produced by means of biological processes involving recombinant DNA technology. Biological drugs have had a profound impact on modern healthcare, offering a new therapeutic approach in medical fields where treatment options were either not available or  inadequate.
  1. Biologics:
 see Biological drugs.
Biopharmaceuticals: see Biological drugs.
  1. Celiac disease:
 Celiac disease is an inheritable autoimmune disorder that is hallmarked by malabsorption, resulting in diarrhea and malnutrition. Classical symptoms include abdominal pain, flatulence, bloating and chronic diarrhea or constipation (or both). Celiac disease affects between 2 to 13 per 100,000 and may appear at any time in a person's life. It increases the risk of gastrointestinal cancer and if left untreated, can become life-threatening.
Chlorhexidine: Chlorhexidine is a chemical antimicrobial substance which can be applied to living tissues to reduce the possibility of infection by micro-organisms. It is often used as an active ingredient in bactericidal mouthwash.
  1. Crohn’s disease:
    Crohn’s disease is a condition of chronic inflammation, potentially involving any part of the gastrointestinal tract from mouth to anus. Affected persons usually experience the cardinal symptoms of diarrhea (or constipation), abdominal pain and, often, weight loss. Frequent complications include blockage of the intestine, sores that may affect surrounding tissue (bladder, vagina or skin), fistulas (tunnels) that often necessitate surgery and fissures (small tears in the lining of the mucosal membrane of the anus). Crohn’s disease has a yearly incidence of 4 to 10 per 100,000 and the peak age at diagnosis is 15-25 years.
  1. Cytokines:
 Cytokines are group of relatively small proteins and peptides that are produced by a wide variety of animal and plant cells to communicate with each other. Cytokines are signaling molecules that play a central role in the immune system and developmental processes.
  1. Diabetes:
 Diabetes is a syndrome characterized by disordered metabolism and inappropriately high blood sugar levels (hyperglycemia). Type 1 diabetes is an autoimmune disease that results in the permanent destruction of insulin‑producing cells in the pancreas, whereas Type 2 diabetes is the most common form of diabetes and is characterized by reduced responsiveness of body tissues to insulin, often combined with reduced insulin secretion. Both types result in excessive amounts of glucose circulating in the blood. Diabetes can cause many serious complications if the disease is not adequately controlled and often requires lifelong injection of exogenous insulin and/or intake of anti‑diabetic drugs.
Fermentation: (Industrial) technique to rapidly produce sufficient biomass of a specific micro‑organisms in a selected growth medium.
Freeze-drying: Freeze-drying (also referred to as lyophilization) is a dehydration process typically used to preserve specific materials or micro-organisms.
  1. Gastrointestinal system:
 The human gastrointestinal (GI) system is a large and complex organ, integrating multiple physiological processes ranging from food intake to regulation of immunity, energy balance and metabolism. Hence, the GI system is an attractive target organ for delivery of innovative drugs that can interfere with these crucial processes to alleviate or cure a variety of important diseases.
Gluten: Gluten is a composite of the proteins gliadin and glutenin and can be found in all forms of wheat and related grains. Gluten sensitivity and intolerance affect up to 1% of the wheat-eating populations in the world and can give rise to serious diseases such as Celiac disease.
  1. Hyperglycemia:
 A condition hallmarked by excessive amounts of glucose circulating in the blood (please refer to diabetes).
Immunoglobulin E: (IgE) One of the five antibody isotypes found in mammals. IgE is involved in Type 1 hypersensitivity and binds to allergens, triggering histamine release from mast cells and basophiles. Mast cells and basophiles coated by IgE are "sensitized", meaning exposure to the same allergen later-on, results in increased vasodilation and smooth-muscle contraction. The reaction may be either local or systemic and an acute, systemic reaction (anaphylaxis) can even prove fatal.
Inflammatory bowel disease: Inflammatory bowel disease (IBD) is the collective name for ulcerative colitis and Crohn’s disease and affects 0.5-1% of the Western world’s population. Patients experience a range of gastrointestinal symptoms, including diarrhea, rectal bleeding and abdominal pain, resulting in weight loss as well as other extra intestinal manifestations such as skin and eye disorders. IBD is a chronic disorder and patients generally require lifelong treatment.
Insulin: Insulin is a hormone secreted by Islet cells within the pancreas. Insulin is secreted in response to an increase in blood sugar and activates cell receptors which subsequently absorb glucose (sugar) from the blood stream into the inside of the cell. Without insulin, circulating levels of glucose rise (hyperglycemia) and  cells can not access their main energy source (please refer to hyperglycemia and diabetes).
Interleukin-10: IL-10 is an important signaling molecule (cytokine) that plays a critical role in the immune system. It has powerful anti-inflammatory properties and acts as a central factor in the induction and maintenance of immune tolerance. IL-10 was discovered many years ago but to date its therapeutic potential has not been exploited fully.
Lactic acid bacteria: Lactic acid bacteria constitute a diverse group of bacteria that produce lactic acid during fermentation. As such, they play an important role in the food industry, mainly in the preparation of dairy products.
  1. Lactococcus lactis:
 L. lactis is the species used for creating ActoBiotics™. It is one of the most important micro-organisms in the food industry and is widely recognized as safe. L. lactis is critical for manufacturing dairy products such as buttermilk, yogurt and cheese and is also used to prepare pickled vegetables, beer, wine, some types of bread and sausages and other fermented foods.
Lyophilization: see freeze-drying.
Mucosa: The mucosa or mucous membranes line various body cavities exposed to the external environment and internal organs. They are generally involved in absorption and secretion, consist of several layers and are covered by epithelial cells.
Mucositis: Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, usually as an adverse event of chemo- and/or radiotherapy treatment for cancer. Oral and gastrointestinal mucositis can affect up to 100% of patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, 80% of patients with malignancies of the head and neck region receiving radiotherapy and a wide range of patients receiving chemotherapy.
Obesity: Obesity is a condition in which the natural energy reserve, stored in the fatty tissue, is increased to a point where it is associated with certain health conditions or even increased mortality.
Oral mucositis: Oral mucositis is the (painful) inflammation and ulceration of the oral mucosa. Cardinal symptoms include ulcerations, debilitating pain and inability to eat or sustain anti-cancer therapy. Ulcers can reach a diameter of 4 cm and oral mucositis can be severely painful, resulting in speaking and eating difficulties or even trouble opening the mouth. Approximately 50% of chemotherapy patients develop such severe mucositis that the patient's anti-cancer treatment must be tempered.
Phase 1 clinical trial: Phase 1 trials are the first stage of testing in human subjects (a small group of healthy volunteers, or patients when deemed appropriate). These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff, and are aimed at providing first indications of safety and tolerability of the study drug in humans.
Phase 2 clinical study: Once the initial safety of the study drug has been confirmed, Phase 2 trials are performed on larger groups to asses efficacy of the study drug and to continue the safety and tolerability evaluations. A Phase 2a clinical study is specifically designed to assess dosing requirements, whereas a Phase 2b trial is geared more towards showing efficacy.
Peptide: Peptides are short polymers of linked amino acids. Proteins are polypeptides.
Regulatory T cell: Regulatory T cells are crucial for the maintenance of immunological tolerance (please refer to T cells). They shut down immunologic reactions towards the end of an immune response and suppress auto-reactive (auto-immune) T cells that escape the process of negative selection in the thymus.
Satiety factors: Satiety factors can be considered as feedback signals, regulating appetite/food intake, metabolism and body weight. As such, satiety factors hold promising therapeutic potential for the treatment of obesity.
Surgical resection: Surgical removal of a specified anatomical part.
T cell:  T cells are lymphocytes (type of white blood cells) produced in the thymus and carry a special receptor on their cell surface (T cell receptor). They play a central role in the body’s immune system and various T cell types are engaged in processes ranging from regulating the immune response to providing the immune system with a “memory” of past infections.
Thymine/Thymidine: Thymine is one of the four bases in the nucleic acid of DNA. Thymine combined with deoxyribose creates the nucleoside deoxythymidine, which is synonymous with the term thymidine.
TopAct™: TopAct™ is ActoGeniX’s versatile and proprietary technology platform which makes it possible to genetically engineer bacteria into efficient production vehicles for the delivery of therapeutic proteins and peptides into the GI tract. ActoGeniX has chosen the food bacterium Lactococcus lactis as the preferred micro-organism for the application of TopAct™.
Trefoil factors: Trefoil factor peptides are characterized by a specific trefoil domain that contains three loops. They are highly stable secretory proteins, expressed in gastrointestinal mucosa. Trefoil factors are believed to protect the mucosa from insults and to promote mucosal healing after injury.
Ulcerative colitis: Ulcerative colitis specifically affects the large intestine or colon and results in characteristic ulcers or open sores. Cardinal symptoms include bloody diarrhea, abdominal pain, fever, obstruction, weight loss and an increased risk of colon cancer. Ulcerative colitis is an intermittent disease, with silent and active periods, and has a yearly incidence of 3 to 15 per 100,000. The peak ages at diagnosis are 15-25 years and 55-65 years. Ulcerative colitis can be associated with various complications outside of the colon, including ulcers in the mouth, inflammation of the iris, arthritis, inflammation of subcutaneous tissue, thrombosis and pulmonary embolism, and anemia.