WILEX AG

uPA system

Claudia Burmester — Fri, 11 Nov 2011 14:53:19 +0000

Urokinase-specific plasminogen activator (uPA) system. A protein lysing enzyme system which plays an important role in the growth, spread and metastasis of different malignant tumours

Standby Equity Distribution Agreement (SEDA)

Claudia Burmester — Fri, 11 Nov 2011 14:52:46 +0000

An increasingly common financial instrument in the biotech industry. It authorises a company to issue new shares from authorised capital and sell them in tranches to the provider of the SEDA

Specificity

Claudia Burmester — Fri, 11 Nov 2011 14:51:58 +0000

Percentage of the actual negatives correctly identified as such; ability to exclude a disease (accurate diagnosis that there is no renal cell cancer)

Special Protocol Assessment (SPA)

Claudia Burmester — Fri, 11 Nov 2011 14:51:33 +0000

The SPA documents that the FDA confirms that the design and planned analysis of a clinical trial adequately address the requirements for a regulatory submission

Solid tumours

Claudia Burmester — Fri, 11 Nov 2011 14:50:59 +0000

Solid growth of tissue

Serine protease

Claudia Burmester — Fri, 11 Nov 2011 14:50:36 +0000

A type of peptidase (i. e. enzymes which catalyse the split of proteins and peptides)

Sensitivity

Claudia Burmester — Fri, 11 Nov 2011 14:50:14 +0000

Percentage of the actual positives correctly identified as such; ability to identify a disease (accurate diagnosis of renal cell cancer)

REDECT

Claudia Burmester — Fri, 11 Nov 2011 14:49:45 +0000

Renal Masses: Pivotal Trial To Detect clear-cell RCC with pre-surgical PET/CT. REDECT is a Phase III registration trial, which will evaluate whether imaging with REDECTANE® can improve the diagnosis in comparison to the current standard (CT)

Receptor

Claudia Burmester — Fri, 11 Nov 2011 14:49:19 +0000

A protein usually found on the surface of cells to which a specific chemical messenger, for example a hormone, binds

Randomised trial

Claudia Burmester — Fri, 11 Nov 2011 14:48:49 +0000

Clinical trial for which the subjects are divided into several groups according to the principle of random selection (randomised)

Preclinical

Claudia Burmester — Fri, 11 Nov 2011 14:48:19 +0000

Comprises all in vitro and in vivo test systems for examining the features of a substance prior to the start of the clinical phases

Pre-BLA Meeting

Claudia Burmester — Fri, 11 Nov 2011 14:47:50 +0000

Pre-Biological License Application Meeting: Official preliminary discussion regarding the possible filing of a marketing application with the US Food and Drug Administration (FDA)

Positron emission tomography (PET)

Claudia Burmester — Fri, 11 Nov 2011 14:47:07 +0000

A radionuclide imaging procedure, which can visualise biochemical and physiological processes by means of radioactive materials

Plasminogen

Claudia Burmester — Fri, 11 Nov 2011 14:46:30 +0000

Precursor of plasmin, an enzyme that dissolves blood clots

Placebo

Claudia Burmester — Fri, 11 Nov 2011 14:46:03 +0000

Dummy drug with no active ingredients

PI3K

Claudia Burmester — Fri, 11 Nov 2011 14:45:39 +0000

The phosphatidylinositol-3-kinase-B signalling pathway sends a “growth” signal to the nucleus of a tumour cell

Phenotype

Claudia Burmester — Fri, 11 Nov 2011 14:45:13 +0000

Physical appearance or outwardly observable characteristics of an organism

Phase III

Claudia Burmester — Fri, 11 Nov 2011 14:44:36 +0000

Clinical trial with a large number of patients (several hundred to several thousand) to ascertain the safety, tolerance and efficacy as well as optimum dosage of a substance under real therapy condition

Phase II

Claudia Burmester — Fri, 11 Nov 2011 14:44:03 +0000

Clinical trial with a low number of patients with the aim of testing the efficacy of a substance for specific indications, identifying any side effects and safety risks and determining the tolerance and optimum dosage

Phase I

Claudia Burmester — Fri, 11 Nov 2011 14:43:30 +0000

Clinical trial of a substance carried out on a low number of healthy subjects or patients, under strict supervision. It is used to determine toxicity, pharmacokinetics, form of administration and safe dosage of a substance