Glossary of Terms Used on this Site

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Angiogenesis: Development of new blood vessels, for example, in the embryo, in wounds, and in the growth and diffusion of tumors. An "anti-angiogenic" compound inhibits such development and therefore, in the oncology field, inhibits the growth of tumors.

Anthracyclines: A class of anticancer agents. Examples are doxorubicin, daunorubicin, and daunomycin.

Antibody: A special protein produced by the body that is capable of recognizing another protein (referred to as an antigen). Antibodies are normally produced by the body in response to infection. The antibody is able to recognize the surface of the invading bacteria or virus, therefore marking it for destruction by the immune system. Technological advances have allowed antibodies to be used as therapeutics for the treatment of a variety of diseases, including cancers. In the case of cancer, the antibody is designed to recognize a protein found on the surface of cancer cells, therefore causing an immune reaction which eliminates them.

Camptothecins: Naturally occurring plant alkaloid compounds, which are known to have unique cancer-fighting properties.

Cancer: A disease caused by the abnormal proliferation (division) of the body's cells. Many different cell types within the body can become cancerous and the disease is normally caused by genetic changes that disrupt the normal control of cell division. Rapidly dividing cancerous cells normally form a mass, or tumor, which puts pressure on and physically invades surrounding tissue.

Carcinoma: Cancers that were originally derived from epithelial cells (i.e. cells that comprise membranes within the body).

Cardiac: Concerning the heart or heart function.

Cardiotoxicity: Damage to the heart caused by a chemical agent.

Catheter: A tubular instrument to allow passage of fluid from or into a body cavity or blood vessel.

Cells: The microscopic, self-contained units that make up all living organisms.

Cell differentiation: The acquisition or possession of one or more characteristics or functions different from that of the original type.

Chemical library: A large collection of chemical compounds that are commonly used in the initial stages of drug discovery. Chemical libraries are commonly screened to identify compounds that will inhibit the action of a clinical target.

Chemotherapy: In the treatment of disease, the application of chemicals or drugs specifically for their anticancer toxic properties. They are given into a vein, muscle, cerebrospinal fluid, or by mouth.

Chromosome: Structures inside cells that contain the genes. There are about 2,000 genes on each of the 46 chromosomes in a human being. The number and shape of the chromosomes sometimes change in leukemia patients.

Cisplatin: See "Platinum"

Clinical target: A molecule within the body, usually a protein, that is thought to be involved in the development of disease. In modern drug development, the identification of a clinical target is often the first step in the development of a potential drug (investigational medicinal product), as compounds that inhibit its mechanism of action can then be identified.

Clinical trial, phase I: The first studies of a new drug candidate in people. Phase I studies are designed to evaluate how a new drug candidate should be given and identify the highest tolerated dose, and evaluate the way the body absorbs, metabolizes, and eliminates the compound.

Clinical trial, phase II: A phase II trial is designed to continue to test the safety of the drug candidate, and begins to evaluate whether and how well the new drug candidate works. Phase II trials often enroll large numbers of patients and may be conducted at many doctors' offices, clinics and cancer centers nationwide.

Clinical trial, phase III: These studies test a new drug candidate, a new combination of drugs +/- a drug candidate, or a new surgical procedure in comparison to the current standard of treatment or a placebo. A participant will usually be assigned to the standard treatment group or the new treatment group at random. Phase III trials often enroll large numbers of patients and may be conducted at many doctors' offices, clinics and cancer centers nationwide.

Combination therapy: A group of drugs used together in a particular way for the treatment of a disease. Combination treatment is commonly used in cancer.

Complete remission: See "Remission."

Complete response (CR): Apparent disappearance of the tumor or tumors from the patient's body (along with other possible criteria, depending on the cancer type.)

Consolidation: A post-induction therapy that is used to improve the outcome of treatment.

Cremaphor: A solubilizing agent, making other compounds soluble, dissolvable

Cytotoxic: Most cancer drugs are cytotoxic agents. These agents selectively damage cells that are rapidly dividing. Since tumor cells are normally in a state of rapid division, this explains the ability of these agents to reduce tumor growth and in some cases bring about tumor shrinkage.

DNA: Deoxyribonucleic Acid. The chemical that carries the genetic information that controls the development of living organisms.

DNA intercalators: A family of cytotoxic agents used in the treatment of cancer and multiple sclerosis. These drugs inhibit the division of tumor cells through interacting with DNA and preventing the process of DNA replication, which occurs before cell division.

Docetaxel: an agent used in cancer chemotherapy that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells.

EDGAR: Stands for Electronic Data Gathering Analysis and Retrieval. EDGAR Online is a private commercial service that gives the professional and individual users electronic access to the critical business, financial and competitive details of every U.S. public company that is required to disclose of its activities to the Securities and Exchange Commission (SEC).

Efficacy: Term used to describe the therapeutic activity of a particular treatment.

EMEA: European Medicines Evaluation Agency. The inter-governmental agency responsible for approving drug candidates for marketing in the European Union.

Enzyme: A protein that acts as a catalyst to induce chemical changes in other substances, itself remaining apparently unchanged by the process.

Epothilones: A family of compounds that are produced by soil bacteria and have anti-cancer effects. Epothilones have a similar mechanism of action to the taxanes (e.g. paclitaxel); both types of compounds bind to the cell protein tubulin thereby preventing cancer cells from dividing and causing them to die by the process of apoptosis.

Equity securities: Any stock or similar security, certificate of interest or participation in any profit-sharing agreement, preorganization certificate or subscription, transferable share, voting trust certificate or certificate of deposit for an equity security, limited partnership interest, interest in a joint venture, or certificate of interest in a business trust; or any security convertible, with or without consideration into such a security, or carrying any warrant or right to subscribe to or purchase such a security; or any such warrant or right; or any put, call, straddle, or other option or privilege of buying such a security from or selling such a security to another without being bound to do so.

Fast track designation: A program developed by FDA that expedites the development of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

FDA: Food & Drug Administration of the United States Department of Health and Human Services.

First-line: First treatment generally adopted for a given diagnosed illness.

Gene: A unit of genetic information that contains the instructions on how to synthesize a single protein, or family of closely related proteins.

Human serum albumin: Serum albumin is the major plasma protein (approximately 60 percent of the total). It serves as a transport protein carrying large organic anions, such as fatty acids, bilirubin, and many drugs. Human serum albumin is albumin extracted from human serum.

Human Genome Project: International scientific effort to map all of the approximately 100,000 genes on the 23 human chromosomes and, eventually, to sequence the 3 billion DNA base pairs that make up these genes. Begun in 1990 and centered in the U.S. and France, the study's goal is to understand the basis of genetic diseases like muscular dystrophy and Alzheimer's disease and to gain insight into human evolution.

Incidence: The number of new cases of a disease which are diagnosed in a population within a fixed period of time.

Indication: The disease and patient population that a drug is approved to treat.

Induction or 'remission induction': Administration of medication or other therapy to bring a patient into a state in which all visible cancer cells have disappeared from the body.

Infusion: The introduction of fluid other than blood, e.g., saline solution, into a vein.

Inhibit: The process by which a compound prevents, or suppresses, the normal mechanism of a biological molecule. By inhibiting a biological molecule an inhibitor may be able to prevent or reduce a disease process and therefore have potential as a therapeutic.

In-licensing: Acquiring (for a fee) the intellectual property rights to use or commercialize programs or products.

Investigational new drug (IND) Application: An application that a drug sponsor must submit to FDA before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including its structural formula, animal test results, and manufacturing information.

In vitro: In an artificial environment, referring to a process or reaction occurring therein, as in a test tube or culture media.

In vivo: In the living body, referring to a process or reaction occurring therein.

Irinotecan: A drug for the treatment of colorectal cancer. It works by blocking an enzyme, called topoisomerase I. The cell needs this enzyme to divide and grow into two new cells. If this enzyme is blocked by irinotecan, then the cell's DNA gets tangled up and the cell cannot divide.

Leukemia: A rapidly progressing cancer (malignancy) of the bone marrow and blood characterized by an uncontrolled growth of white blood cells. There are three major types:

Acute myelogenous leukemia (AML): Leukemias where the bone marrow contains immature cells of the myeloid type. There are an estimated 10,000 new cases annually. (Acute promyelocytic leukemia, or APL, is a sub-type of AML.)

Licensing: The buying and selling of the marketing rights to drugs and potential drugs.

Lymphoma: A tumor derived from immune system cells that grows in the lymphatic system (a system of tubes that drain fluid from the body). Lymphomas are either classifies as Hodgkin's lymphoma (around 10% of cases in terms of incidence), or non-Hodgkin's lymphoma (around 90% of cases).

Maintenance therapy: A therapeutic regimen intended to preserve benefit.

Malignant: Resistant to treatment; occurring in severe form, and frequently fatal; tending to become worse and leading to a course of increasing severity. In cancer, malignant tumors are those that are locally invasive and destructive and that can spread to other parts of the body.

Molecular remission: Remission documented by a sensitive molecular test which shows that no genetic abnormalities characteristic of the disease in question remain.

Molecular relapse: Relapse documented by a sensitive molecular test which shows that genetic abnormalities characteristic of the disease in question have recurred.

Monoclonal: Pertaining to a protein from a single clone of cells, all molecules of which are the same; e.g., in the case of Bence Jones protein, the chains are all kappa or lambda.

NDA: New Drug Application. The process used to request marketing approval for a potential new drug from the U.S. Food and Drug Administration.

Non-Hodgkin's lymphoma: See "Lymphoma"

Oncology: The study of cancer.

Orphan drug: A drug that has only a limited target population or that treats a rare disease.

Orphan Drug Designation: The intent of orphan drug designation is to stimulate the research, development and approval of products that treat rare diseases. If a product with an orphan drug designation subsequently receives the first FDA or EMEA approval for the indication for which is has such designation, the product is entitled to orphan drug marketing exclusivity. This means that the regulatory agency may not approve any other applications to market the same drug for the same indication, except in very limited circumstances, for a period of seven (U.S.) or 10 (EU) years. Sponsors also are granted tax incentives for clinical research they have undertaken in the U.S.

Out-license: Receive fees from a third party for the rights to use or commercialize programs or products.

Paclitaxel: An agent used in cancer chemotherapy that binds to microtubules promoting the assembly of tubulin sub-units to inappropriate structures which ultimately leads to cell death.

Partial remission: See "Remission."

Partial response (PR): One of the parameters that is used to assess the activity of potential anti-cancer drugs. In solid tumors, according to the RECIST criteria, a partial response is a 30% or more decrease in the diameter of the tumor at its longest point.

PG: polyglutamate; a polymer chain made up of glutamic acid residues

PG-conjugate technology: Proprietary technology in which different agents, especially chemotherapeutics, may be linked to a polyglutamic acid chain to form a macromolecule. The macromolecule generally has different pharmacokinetic characteristics from the chemotherapeutic agent when used alone.

Pharmacokinetics: The study of how drugs and potential drugs are absorbed, distributed, and finally eliminated from the body, in addition to how they are altered or broken down by the metabolism. Essentially, pharmacokinetics asks: How quickly is the drug taken up by the body, where in the body does it go, and how long does it stay there?

Phase I, II, III clinical trials: See Clinical Trials.

Pipeline: The series of products that a company has under development.

Pivotal study/trial: Clinical trial on which a drug's safety and efficacy is based.

Platinum based compounds: A family of cytotoxic drugs commonly used for the treatment of cancer and that contain one or more platinum atoms in their chemical structure. These drugs inhibit the division of tumor cells by interacting with DNA and preventing the process of DNA replication that occurs before cell division.

Polyglutamate paclitaxel (CT-2103, XYOTAX™): Is comprised of paclitaxel molecules covalently linked through an ester bond to poly-L-glutamate to form a macromolecular drug.

Polyglutamate camptothecin (CT-2106): Is comprised of a camptothecin molecule linked through an an ester bond to poly-L-glutamate to form a macromolecular drug.

Polymer: A substance of high molecular weight, made up of a chain of repeated units.

Preclinical: Studies used to predict the potential safety, tolerability, and activity of a potential drug before it has entered clinical trials in humans.

Prevalence: The proportion of people in the whole population who are found with a particular disease at any one point in time, without taking into account when they first were diagnosed with the disease.

Priority review: A process by which FDA generally expects to review a New Drug Application (NDA) within six months of filing. Priority review is granted for drug candidates for conditions that, if approved, would be a significant improvement compared to available treatments for serious or life-threatening conditions.

Private equity: Investments made in private companies.

Proteins: Biological molecules involved in many processes in living organisms: proteins are involved in controlling the metabolism of cells, controlling the structure and movement of cells and larger structures and coordinating the response of cells to internal and external factors. The structure and activity of proteins is specified by the genetic information in DNA and so can be seen as carrying out the instructions contained in DNA.

Protocol: A description of the purpose, objectives, methods, data collection and planned analysis for a clinical study.

Radiation therapy: Also known as radiotherapy, it is the use of high-energy radiation to kill cancer cells. External radiation therapy uses a machine outside of the body to deliver the energy beam. Internal radiation therapy uses small inserts that deliver radiation to limited areas inside the body.

Refractory: A condition that is resistant to ordinary treatment.

Regimen: The exact way a drug or group of drugs is administered to patients in the treatment of a disease.

Relapse: Following a period of improvement, relapse is a return of the signs and symptoms of a disease.

Remission: Complete remission means that all detectable cancer cells have disappeared from the body and that biologic tumor markers, if any, have returned to normal levels. Partial remission implies improvement, although some evidence of disease remains.

Response rate: The proportion of patients that show a physical decrease in the size of their tumors in response to a particular treatment.

Screening: A test to identify compounds with potential therapeutic activity.

Second-line: The second treatment that is normally given to a patient with a particular diagnosis, some time after first-line treatment. Patients receiving second-line treatment have normally relapsed following the first treatment they received, or failed to respond to this first treatment.

Shares outstanding: The number of shares of common stock currently outstanding - the number of shares issued minus the shares held in treasury. Shares Outstanding reflects all offerings and acquisitions for stock made after the end of the previous fiscal period.

Single-agent: When a therapeutic agent is used alone, it is known as a single-agent treatment.

Solid tumors: A cancer that originates in organ or tissue other than bone marrow or the lymph system.

Solubilizing: Dissolving one material into another.

Special protocol assessment (SPA): A two sided binding agreement made between the sponsor of a product in clinical trials and the FDA that states that a pivotal trial is appropriately designed to provide the clinical data needed for a marketing authorization.

Taxanes: A class of antitumor agents derived directly or semisynthetically from Taxus brevifolius, the Pacific yew; examples include paclitaxel and docetaxel.

Topotecan: A topoisomerase I inhibitor with antitumor activity.

Tubulin: A protein subunit of microtubules; it is a dimer composed of two globular polypeptides, alpha-tubulin and beta-tubulin.

Tumor: A swelling or growth caused by the abnormal division of cancer cells.