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Entolimod

Extended indication Acute radiation syndrome
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Entolimod
Domain Oncology and Hematology
Main indication Oncology other
Extended indication Acute radiation syndrome
Manufacturer cleveland-biolabs
Route of administration Intramuscular
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Recombinant protein that acts as an agonist of toll-like receptor 5 (TLR5). Entolimod activation of TLR5 triggers NF-kB signaling, mobilizing an innate immune response.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date November 2017
Expected Registration December 2018
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Geen
Therapeutic value No judgement
Dosage per administration 0,4-0,6 μg/kg
References Krivokrysenko et al. Predicting a human efficacious dose range for entolimod (CBLB502) based on biomarkers of its anti-radiation efficacy. Chemical and Biological Defense Science and Technology Conference, 2015.
Additional remarks Eenmalige injectie

Expected patient volume per year

Patient volume

< 17

Market share is generally not included unless otherwise stated.
References EMA
Additional remarks EMA orphan designation: "less than 0.01 in 10,000 people in the European Union (EU)." Voor Nederland zou dit uitkomen op 17 patienten per 17M inwoners.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Solide tumoren, vaccin adjuvant.
Additional remarks Een mogelijk probleem bij de indicatie-uitbreiding voor solide tumoren is dat de stralenbescherming die als het werkt, ook op de tumor werkt. Op dit aspect zijn de trials niet gericht. De werkgroep verwacht dat het gebruik van entolimod voor deze indicatie dan ook laag zal zijn.

Other information

There is currently no futher information available.