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Hypericin

Extended indication Patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Hypericin
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Manufacturer Soligenix
Mechanism of action Other, see general comments
Route of administration Cutaneous
Therapeutical formulation Ointment
Budgetting framework Intermural (MSZ)
Additional remarks Synthetic hypericin, the active ingredient in SGX301, tends to accumulate in T-cells. Once the hypericin is in the T-cells, it can be activated by safe, visible fluorescent light. When synthetic hypericin is activated it creates oxygen radicals which subsequently cause cellular toxicity, killing the targeted T-cells. Amerikaanse merknaam: Hybryte, merknaam in Nederland en of Europa nog niet bekend

Registration

Registration route Centralised (EMA)
Submission date 2023
Expected Registration 2024
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Estimated primary completion datum in december 2019.

Therapeutic value

Current treatment options Er bestaat een duidelijke unmet clinical need voor de behandeling van patiënten met een CTCL. In Nederland zijn hiervoor nauwelijks topicale behandelingen beschikbaar. Een voorbeeld therapie is systemische chemotherapie.
Therapeutic value Possibly no place in the treatment regimen
Substantiation Er zijn in vitro studies van hypericine die duiden op antiproliferatieve effecten en als topicaal product zijn er aanwijzingen dat het als fotosensitiser kan werken. Er wordt verwacht dat het weinig tot niet voorgeschreven gaat worden.
Frequency of administration 1 times every 2 weeks
References NCT02448381
Additional remarks 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.

Expected patient volume per year

Patient volume

< 126

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Er is een incidentie van126 patiënten cutane t-cellymfomen in 2018. Er wordt verwacht dat het weinig tot niet voorgeschreven gaat worden

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.