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sitimagene ceradenovec

L01XL01

Forms & Strengths

Intracavitary suspension for injection
Viral vector concentration provided per specific protocol

Adult Dosing

Administered via injection directly into the tumor bed following surgical resection
Used in combination with valganciclovir prodrug therapy
Dosage and administration protocols are highly specialized and restricted to clinical trials or specialized oncology centers

Pediatric Dosing

Safety and efficacy in pediatric patients have not been established
Not recommended for use in pediatric populations outside of approved clinical trials

Indications

Investigational gene therapy for malignant gliomas (e.g., glioblastoma multiforme)
Used alongside ganciclovir or valganciclovir as a suicide gene therapy approach

Mechanism of Action

Replication-deficient adenovirus vector containing the herpes simplex virus thymidine kinase (HSV-tk) gene
Delivers the HSV-tk gene into tumor cells, which then phosphorylates the co-administered prodrug (valganciclovir/ganciclovir)
Incorporation of the phosphorylated drug into viral and cellular DNA inhibits DNA synthesis, leading to cell death and a bystander effect

Contraindications

Hypersensitivity to the active substance, adenovirus vectors, or any excipients
Active systemic infection
Contraindications related to concomitant antiviral medications

Adverse Reactions

Fever and flu-like symptoms
Cerebral edema and increased intracranial pressure
Headache, seizure, and neurological deficits
Local injection site reactions and inflammation

Drug Interactions

Concomitant use with other immunosuppressants may alter vector clearance and immune response
Interacts synergistically with ganciclovir or valganciclovir (intended therapeutic interaction)
Potential interference from other live viral vaccines

Curated Content: Needs Vetting Before Put to Clinical Use