STROKE
Stroke is defined as a sudden neurological deficit attributed to an acute focal injury of the central nervous system by a vascular cause. Stroke can be broadly classified into ischaemic stroke (80-90% cases) and haemorrhagic stroke (10-20% cases).
Stroke is a leading cause of disability, with an increasing incidence in developing countries. Approximately one million people in Europe and around 800,000 in the USA have a stroke each year. Worldwide, 15 million people suffer stroke per year, and mortality from such is the leading cause of death in many countries in the world.
These techniques reduce disability but are time-critical:
STROKE
AIS treatment
The initial clinical deficit presented by patients with stroke is due to a hypoperfused region of the brain called the ischaemic penumbra. The collateral blood supply in this region can be sufficient to maintain cellular viability for a period of time. Thus, with rapid reperfusion, this penumbral brain can be salvaged and can recover normal function. Nevertheless, when not recognized and treated within an immediate timeframe upon onset of symptoms, the salvageable ischaemic penumbra can progressively convert to irreversibly injured tissue over time, known as ischaemic core.
Current management of ischaemic stroke focuses on rapid reperfusion with intravenous thrombolysis (IVT) and endovascular thrombectomy.
TECHNIQUES
Intravenous thrombolysis (IVT):
Is the only approved systemic reperfusion treatment for patients with acute ischaemic stroke. IVT reduces disability when administered within 4.5h of the onset of the stroke, although it can also be beneficial in patients with evidence of salvageable brain tissue via CT or MRI imaging core perfusion mismatch for up to 9h and in patients who awake with stroke symptoms demonstrating MRI DWI-FLAIR mismatch.
Endovascular thrombectomy:
It reduces disability in patients with large vessel occlusion when performed within 9h of stroke onset and in patients with evidence of salvageable brain tissue up to 24h following stroke onset.
Current guidelines can be found here.
STROKE
Hemorrhagic Transformation
To date, reperfusion therapies represent the mainstay of acute ischemic stroke (AIS) treatments. Reperfusion can be performed pharmacologically by the use of intravenous recombinant human tissue-type plasminogen activator (IV tPA; alteplase) within the first 4.5 h after stroke onset, and since 2015, by endovascular therapy (EVT) in case of an anterior circulation large-vessel occlusion (LVO).
However, these treatments are by no means entirely free of complications, with intracranial hemorrhage (ICH) the most feared. Hemorrhagic complications after reperfusion therapies include a broad spectrum of severity between small petechial hemorrhagic infarcts (HIs) to parenchymal hematomas (PHs). ICH, especially with PH, is associated with increased morbidity and mortality. This explains in part why ICH and especially symptomatic ICH (sICH) are mandatory safety outcomes of most AIS RCTs.
know more about
Rates for siCH in IV-tPa trials
know more about
EVT
In 2014, a meta-analysis of individual patient data from nine trials evaluated sICH with the ECASS 3 and SITS-MOST definitions: tPA significantly increased the likelihood of sICH.
Among the 3,391 patients receiving tPA:
%
Had a PH2 within 7 days [231/3391 patients]
VS.
%
In the control group (OR = 5.5, 95% CI = 4.01–7.70) [44/3391 patients]
Similar results were obtained for SITS-MOST–criteria PH2 within 36 h (OR = 6.67, 95% CI = 4.11–10.84). These PH2 cases were fatal within 7 days for 2.7% patients in the tPA group vs. 0.4% in the control group.
Importantly, this early excess mortality caused by ICH in the tPA group did not result in increased overall mortality at 3 months and did not limit tPA effectiveness on 3 month functional outcomes.
Thus, if the increased mortality due to sICH PH events could be severely reduced or even eliminated, IV-tPa effectiveness would drastically increase.
OUR SOLUTION – STROKE
RapidResponse c-Fn™
Prediction BioSciences has developed the RapidResponse c-Fn* assay, which is based on the use of the Cellular Fibronectin (c-Fn) in the blood plasma as a marker for damage of the neurovascular endothelium leading to loss of vascular patency. Thus, RapidResponse c-Fn* will help and guide clinicians’ treatment decision by by identifying patients at a negligible risk of severe neurological bleeding following thrombolytic administration.
BENEFITS
FOR HEALTHCARE AND SOCIETY
Lower death rate/severe disability at 90 days due to hemorrhagic transformation
Much lower per patient cost for AIS
Increase the number of patients that can safely benefit from rapid reperfusion with IVT
Decrease the number of patients that suffer irreversibly tissue injury due to hemorrhagic transformation following IV-tPa administration.
Potentially expand the safe usage of tPa in rural location via ambulatory tele-stroke.
FOR PATIENT AND FAMILIES
Provides invaluable information to make an informed treatment decision in a critical life-death- disability situation
Patients and/or family members, otherwise declining IVT due to fear of bleeding issues, can now confidently receive it
STROKE – UPDATE COMING SOON
CNS Biosimilar H2020 BIOFAST PROJECT
The BIOFAST project brings together complementary expertises and skills in the development of the first CNS biosimilar. Partners and collaborators are from various countries all across Europe.
Our products
PRODUCTS
- RapidResponse c-FN 100%
- Thrombolytic Biosimilar 80%
- MNS-FTD2 47%
- MNS-FTD1 30%
Candidate
Discovery
Candidate
Optimization
Pre-clinical
Stage
Clinical stage
Market stage