Date: 2008-03-05
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Advantagene (USA - MA)
Product: aglatimagene besadenovec (AdV-tk) followed by valacyclovir
Action
mechanism: immunotherapy product/gene therapy. The product is based on Gene Mediated Cytotoxic Immunotherapy™ (GMCI). Upon administration, GMCI will generate a precise and robust patient specific immune response, attacking a patient’s solid tumors, distant metastases, or minimum residual disease. The technology consists of a series of small gauge, relatively painless injections at the tumor site or target tissue followed by the oral administration of an activating prodrug. The initial injections deliver aglatimagene besadenovec (AdV-tk), a gene vector derived from an adenovirus and engineered to deliver the thymidine kinase (tk) gene, derived from the Herpes Simplex virus, to the target cells. The target tissues and cells then produce the TK protein. Cells that multiply in the neighborhood of where the TK protein was delivered and is now expressed then become susceptible to the toxic effects of valacyclivir. Administration of valacyclivir then causes a cytotoxic biochemical reaction at the site of administration that leads to the death of multiplying tumor cells, cells repairing themselves from radiation or chemotherapy damage, and endothelial cells from growing tumor vessels. A subsequent cascade of immuno-stimulatory events, including the production and recruitment of disease fighting cytokines and cancer killing T-Cells, amplified by TK’s “super-antigen” characteristics, stimulates the in situ development of a precise, patient-specific anti-tumor immune effect to combat cancer cells. As a result, massive amounts of newly created T-cells, primary weapons used by the body to fight cancer, now recognize cells expressing a patient’s unique TAAs. These T-cells will identify, attack and destroy cancer cells expressing these antigens both at the site of the tumor and anywhere else in the body. Some of these new T-cells, called memory T-cells, can remain for years, patrolling the body for remaining cancer cells and providing a durable “vaccine like” effect, resulting in the eradication of tumors in some cases or slowing their growth or spread in others.
Disease: glioma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary objective is to determine if this approach is safe and can be effectively delivered without disturbing standard therapy. (NCT00634231)
Latest
news: * On March 5, 2008, a Phase 1 trial sponsored by Advantagene was published on the NIH website ClinicalTrials.gov for aglatimagene besadenovec (AdV-tk) followed by valacyclovir and is currently recruiting participants.
