Extended indication Patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Hypericin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication 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 comments 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.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials
Additional comments Estimated primary completion datum in december 2019.

Therapeutic value

Current treatment options Er bestaat een duidelijke unmet clinical need voor de systemische behandeling van patiënten met een CTCL. In Nederland zijn hiervoor nauwelijks behandelingen beschikbaar. Een voorbeeld therapie is systemische chemotherapie.
Therapeutic value No estimate possible yet
Substantiation Er zijn in vitro studies van hypericine die duiden op anti-proliferatieve 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 comments 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 comments 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.