IPS Therapeutique Cardiovascular Efficacy and Safety Assessment in New Chemical Entities
IPS Therapeutique (IPST) is a specialized contract research organization that dedicates its expertise, experience and technology to the assessment of cardiovascular efficacy and safety in new chemical entities, from discovery on to regulatory submission.
IPST believes that well-characterized, thoroughly mastered models and techniques hold the key to highly predictive, cost-effective pre-clinical science in a successful drug-development strategy.
Pre-clinical cardiovascular studies
Over the last decade, IPST scientists have directed and executed over 1,000 pre-clinical cardiovascular studies, gaining unparalleled experience in strategic planning, study design, experimentation, analysis, interpretation, and presentation of study results.
Sponsor feedback and development successes have highlighted the positive impact that IPST’s scientists can have on drug development programs; their early-stage advice in study design results in optimized experimental outcomes, and their presence at the development team’s table provides the sponsor with immediate expertise in pre-clinical cardiology.
Cardiovascular efficacy and safety assessment
IPST’s assays examine the effect of test articles on the function of native or cloned ion channels (patch-clamp), isolated tissues and perfused organs, and anaesthetized and conscious animals. These assays have been rigorously validated, are fully GLP-compliant and have been designed to fulfill the FDA’s, Health Canada’s, and the European Union’s requirements, while addressing the concerns and suggestions of the ICH S7a & b guidelines. From discovery to IND, or in support of ongoing clinical trials, IPST’s team can assist sponsors worldwide in the assessment of cardiovascular efficacy and safety.
Specialized efficacy and safety services can be executed as screens or in compliance with current GLP guidelines. IPST provides the following services:
hERG and ionic current inhibition assays
Our hERG and ionic current inhibition assays include:
- ICH S7B core battery
- Manual patch-clamp assays conducted at physiological temperature
- HEK293 or CHO cell lines or freshly dispersed cardiac myocytes, stem cell-derived cardiac myocytes
Action potential duration analysis
We offer action potential duration (APD) analysis of:
- Purkinje fibres, papillary muscles, ventricular strips, myocytes and wedges
- High-impedance intracellular measurement and transmural ECG recording
Detection of transmural dispersion of repolarization
To detect transmural dispersion of repolarization (TDR) IPST performs simultaneous three-point measurement of APDs from perfused ventricular wedges. This is a conclusive indicator of pre-arrhythmic potential.
Cardiac and vascular muscle tension measurement
We can perform cardiac and vascular muscle tension measurement of:
- Papillary muscles, atrial or ventricular trabeculae
- Aortic and vascular tissues from rodents, rabbits, dogs and humans
Analysis and monitoring of isolated rat and rabbit hearts (Langendorff)
For both paced and spontaneously beating hearts we can perform complete surface ECG analysis and monophasic action potential (MAP) duration, as well as axial and radial ventricular contractility and coronary tension monitoring.
In vivo animal models
Our in vivo animal models include:
- Induced pulmonary and / or systemic arterial hypertension (rats)
- Induced (overpacing) heart failure (dogs and rats)
- Acute and chronic ischemic remodelling (rats, rabbits and dogs)
- Thrombosis / coagulation measurements (rats / rabbits)
Pre-clinical cardiovascular pharmacology and physiology consulting
IPST also provides expert consulting in pre-clinical cardiovascular pharmacology and physiology.
Products and Services
Predicting TCA Toxicity Using In Vivo and Ex Vivo Juvenile Safety Models
The tri-cyclic antidepressant (TCA) amitriptyline is used in the treatment of nocturnal enuresis at doses of 2-7mg/kg in children, despite existing reports of severe cardiac toxicity at doses of 10mg/kg.
ACE Pharmaceuticals today announced that the first patient has entered the Phase III trial also known as the Levamisole trial. This trial was accepted by the EMEA by November 2006. The goal of this trial, which was accepted by the EMEA in November 2006, is to assess the efficacy and saRead more