| ACS: |
|
Acute Coronary Syndromes (ACS) encompass a range of cardiac diseases including unstable angina, non ST-segment elevation myocardial infarction (NSTEMI) and STEMI, the latter two are also known as heart attacks. |
| |
|
|
| Age-related Macular Degeneration: |
|
An increased production of blood vessels in the eye leading to blindness |
| |
|
|
| ANDA: |
|
An Abbreviated New Drug Application (ANDA) contains data for the review and approval of a generic drug product by the FDA. Generic drug applications are 'abbreviated' because they are not required to include preclinical and clinical data to establish safety and effectiveness. Instead ANDA applicants must be able to prove scientifically that the generic product is bioequivalent, ie it performs in the same manner as the original drug. |
| |
|
|
| Angiogenesis: |
|
A process involving the growth of new blood vessels from existing vessels |
| |
|
|
| Antibiotic: |
|
An agent that kills bacteria or prevents their growth |
| |
|
|
Antithrombotic:
|
|
An agent used for the prevention or treatment of a blood vessel blockage caused by a clot formed at the site of obstruction |
| |
|
|
API:
|
|
Active pharmaceutical ingredient, the chemical substance used in the manufacture of a drug. |
| |
|
|
Arixtra :
|
|
The brand name for the antithrombotic fondaparinux sodium and a registered Trademark of GlaxoSmithKline. |
| |
|
|
| Bioassay: |
|
Biological assay, an experiment used to measure the pharmacological effectiveness of a drug candidate on cells or organisms |
| |
|
|
Bioequivalent:
|
|
Two drugs are said to be bioequivalent if they have the same potency and bio-availability, assuming equal doses |
| |
|
|
cGMP:
|
|
Current Good Manufacturing Practice |
| |
|
|
Chemotherapy:
|
|
A term used to describe the use of chemical agents to kill cancer cells |
| |
|
|
Clinical trial:
|
|
A structured study conducted in a hospital or clinic in which a drug is evaluated for its effects on humans |
| |
|
|
Cytotoxic:
|
|
Any substance that has the properties to harm or destroy cells |
| |
|
|
Diabetic Retinopathy:
|
|
A complication of diabetes triggered by abnormal blood vessel growth in the back of the eye, leaking blood into the centre of the eye, causing severe retinal damage. |
| |
|
|
Drug Candidate:
|
|
A compound selected from the lead optimisation process that has been extensively tested in preclinical models and has the desired safety and efficacy characteristics to be considered for initial testing in humans. |
| |
|
|
Drug Development:
|
|
In broad terms, the process of taking a drug candidate through preclinical testing, IND submission, clinical trials and NDA filing |
| |
|
|
Drug Discovery:
|
|
The process by which chemical compounds with possible therapeutic benefit in man are identified |
| |
|
|
DVT:
|
|
Deep vein thrombosis. The formation of a blood clot in a 'deep vein'. Deep veins occur in arms, legs and the torso. |
| |
|
|
Early Stage:
|
|
Describes programs in the discovery and lead stage |
| |
|
|
Efficacy:
|
|
A measure of a drug's effectiveness. The ability of a drug to control or cure an illness |
| |
|
|
EMEA:
|
|
The European Medicines Agency, a decentralised body of the European Union. The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products. |
| |
|
|
FDA:
|
|
US Food and Drug Administration; the regulatory body for the approval of drugs in the United States |
| |
|
|
Fondaparinux:
|
|
The active pharmaceutical ingredient of Arixtra |
| |
|
|
Generic:
|
|
A generic drug is one that is equivalent to an original drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use |
| |
|
|
GPCR:
|
|
G-protein coupled receptors (GPCRs) are important targets in many diseases including pain, inflammation, cancer, metabolic, gastrointestinal, cardiovascular and central nervous systems disorders. |
| |
|
|
Heparin Drug:
|
|
A therapeutic belonging to the group of anticoagulant drugs consisting of heparin, low molecular weight heparins and fondaparinux. |
| |
|
|
Hit:
|
|
An active compound in any specific biological assay |
| |
|
|
HyACT :
|
|
Hyaluronic acid chemotransport technology. Alchemia's proprietary technology for the delivery of anti-cancer agents to tumour sites |
| |
|
|
Hyaluronic Acid (HA):
|
|
A naturally occurring, linear polysaccharide molecule that is approved and widely used as an injected medical device for the treatment of arthritis and for ophthalmic procedures. In solution HA forms a sponge-like mesh which entraps smaller molecules, forming the basis for the HyACT platform |
| |
|
|
| HA-irinotecan (HyCAMP): |
|
A HyACT formulation of irinotecan for the treatment of metastatic colorectal cancer |
| |
|
|
| HyDOXTM: |
|
A HyACT formulation of the chemotherapy agent doxorubicin, which has completed a Phase I/IIa clinical trial in patients with metastatic cancers |
| |
|
|
| HyFIVETM: |
|
A HyACT formulation of 5-fluorouracil, which has completed a Phase I/IIa clinical trial in patients with metastatic colon cancer |
| |
|
|
HyMEXTM :
|
|
A HyACT formulation of the chemotherapy agent methotrexate, which has undergone in vivo studies |
| |
|
|
in vitro:
|
|
Literally means "in glass", ie in a test tube or in the laboratory. The opposite of in vivo (in a living organism). Or: In an artificial environment, such as a test tube, rather than inside a living organism |
| |
|
|
| Indication: |
|
The specific approved or potential use for a specific drug |
| |
|
|
| IND: |
|
Investigational New Drug Application. A formal US regulatory submission by a company to the FDA prior to initiating a human Clinical Trial intended to demonstrate the safety of a medical procedure or therapy
|
| |
|
|
Irinotecan:
|
|
A cytotoxic drug used for the treatment of metastatic colorectal cancer, marketed by Pfizer under the tradename Camptosar |
| |
|
|
Late Stage:
|
|
Describes programs in Phase II or III, or programs for which a new drug application (NDA) has been filed |
| |
|
|
Lead:
|
|
A lead is an active compound (hit) that meets set selection criteria for further development as a drug candidate |
| |
|
|
Library:
|
|
A collection of chemical compounds, often related by a core structure or function, used in this instance for drug discovery |
| |
|
|
LMWH:
|
|
Low molecular weight heparin. A mixture of smaller fragments of heparin produced by artificially breaking down heparin using either chemical or enzymatic means. |
| |
|
|
Lovenox :
|
|
A low molecular weight heparin (LMWH) produced by Sanofi-Aventis. |
| |
|
|
Mid Stage:
|
|
Describes programs in preclinical or phase I development |
| |
|
|
NCE:
|
|
New Chemical entity. A chemical compound which has not been approved by the FDA for human use |
| |
|
|
NDA:
|
|
New Drug Application. A document in which a drug sponsor formally proposes that the FDA approve a new drug for sale and marketing |
| |
|
|
Oncology:
|
|
The branch of medicine which studies cancer |
| |
|
|
PCT:
|
|
Patent Cooperation Treaty. The objective of a PCT application is to simplify the patent application procedure for simultaneous multiple country filings. |
| |
|
|
Peptide:
|
|
A molecule made of a small number of amino acids (generally 2 to 20) |
| |
|
|
Peptidomimetic:
|
|
A chemical compound that mimics the ability of a peptide to recognize certain physiological molecules, such as proteins and DNA |
| |
|
|
Pharmacokinetics:
|
|
The study of the effects of a drug on the body, encompassing absorption, distribution, metabolism, excretion and toxicity. |
| |
|
|
Phase I Clinical Trial:
|
|
The first phase of testing a new drug or formulation in humans; primarily designed to demonstrate safety and obtain some information on the appropriate human dose. |
| |
|
|
| Phase II Clinical Trial: |
|
The second phase of testing a new drug or formulation in humans; designed to demonstrate safety of the dose (chosen on the basis of Phase I results) and to provide evidence for efficacy (e.g. an anti-tumour effect in the case of cancer drugs). |
| |
|
|
| Phase III Clinical Trial: |
|
The third phase of testing a new drug or formulation in humans; designed to demonstrate safety and/or efficacy that are equivalent or superior to existing therapies, providing the necessary data for obtaining formal approval from the FDA. |
| |
|
|
Pilot-Scale:
|
|
Trial production run to ensure the material can be manufactured at a quality and quantity required to meet commercial supply requirements |
| |
|
|
Platform Technology:
|
|
A proprietary technology which offers an ongoing stream of product opportunites |
| |
|
|
Preclinical:
|
|
The testing of a compound/treatment in animals to measure efficacy and safety prior to testing in humans |
| |
|
|
Primary Endpoint:
|
|
A clinical trial's main result, which is calculated at the end of the study to see if the treatment was successful. The primary endpoint is defined before the clinical study begins |
| |
|
|
Priority Date:
|
|
The initial date of filing of a patent application, normally in the applicant's domestic patent office. This date is used to help determine the novelty of an invention. |
| |
|
|
Progression-Free Survival:
|
|
A term referring to the length of time, during and after treatment, a cancer does not grow. |
| |
|
|
Pulmonary Embolism:
|
|
Blood clot in one of the major arteries that carry blood depleted of oxygen to the lungs. |
| |
|
|
Remission:
|
|
Referring to the absence of active cancer |
| |
|
|
Secondary Endpoint:
|
|
A clinical endpoint supportive of the primary endpoint, through additional clinical characterisation of the treatment effect |
| |
|
|
Statistical Significance:
|
|
A result from a statistical test which indicates whether differences between experimental groups are real or due to chance |
| |
|
|
Super Generic:
|
|
A "high-barrier-to-entry" generic product, differing from the original in formulation or method of delivery |
| |
|
|
Synthesis:
|
|
The formation of a man made chemical compound from simpler compounds by chemical reactions, usually over a number of steps |
| |
|
|
TGA:
|
|
Therapeutic Goods Administration. The Australian Government agency which assesses and monitors activities to ensure medicines in Australia are of an acceptable standard.
|
| |
|
|
Thrombosis:
|
|
A blood vessel blockage by a clot formed at the site of obstruction. This is distinguished from an "embolism", which travels through the bloodstream and lodges, obstructing a blood vessel |
| |
|
|
Time to Treatment Failure:
|
|
An aggregate end point comprised of time to disease progression, time to toxicity or death, or time to initiation of alternate therapy |
| |
|
|
Toxicity:
|
|
The degree to which a drug is poisonous or has an adverse effect on an organism |
| |
|
|
Tumour:
|
|
An abnormal mass of tissue that results from excessive cell division. Tumours perform no useful body function. They may be either benign (not cancerous) or malignant (cancerous) |
| |
|
|
Tumour Response:
|
|
Evidence of tumour shrinkage by clinical or radiological data |
| |
|
|
Universal Library:
|
|
A large collection of chemical compounds which are designed to mimic near all peptide conformations |
| |
|
|
| VASTTM |
|
Versatile Assembly on Stable Templates. Alchemia's carbohydrate based drug discovery platform technology. VASTTM enables rapid synthesis of libraries of compounds that effectively scan three dimensional space |