A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma

Date receipt dossier

EudraCT number

2004-000464-28

Company / Sponsor

Ark Therapeutics Ltd

Phase

III

Treated organism

Humans

Indication category

Cancer therapy

Disease

Operable high-grade glioma

Therapeutic approach

Suicide gene/ pro drug

Genetic modification

Thymidine Kinase (HSV-TK1)

Method of transfer of nucleic acid of interest

Human Adenovirus serotype 5

Administered biological material

Recombinant Adenovirus D (E1, E3)

Route of administration

Intratumoral

Locations in Belgium

Academisch Ziekenhuis - Vrije Universiteit Brussel;
Cliniques Universitaires de Bruxelles - Hôpital Erasme;
Centre Hospitalier Universitaire de Liège.

Type of procedure

Contained use only

Current status

Authorized

Pharmaceutical study code

Protocol 904

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