Adenoviral Mediated Interleudkin-12 Gene Therapy for Metastatic Breast Cancer
Annual rept. 1 Oct 2003-1 Oct 2004
MOUNT SINAI SCHOOL OF MEDICINE NEW YORK
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Our preclinical studies in tumor-bearing mice have shown that intratumoral injection of an adenoviral vector expressing interleukin-12 was effective in inducing tumor regression, antitumor immune responses and long term survival without disease relapse in 40 treated animals. Based on these findings, we have developed a Phase I trial of intratumoral delivery of an adenoviral vector Adv.RSV-hIL12, ADV-hIL12 expressing the human interleukin-12 cDNA in patients with metastatic breast cancer to the liver. We have completed preclinical efficacy and toxicity studies to support an IND application to the FDA to conduct the proposed clinical trial. Revisions to the clinical protocol and consent have been made on the recommendations of the FDA and NIH-OBA. We have successfully completed clinical grade production of the study agent Adv.RSV-hIL12 in the Vector GMP Facility at Mount Sinai. The IND was approved by the FDA 61102. The revised protocol and consent was submitted to the Department of the Army 61702 for approval. The Human Subjects Protection Division of the Department has granted approval on 101704 after further revisions were made at their request. The clinical trial will be activated for patient accrual once the revisions requested by the HSPD have been approved by the local IRB.
- Genetic Engineering and Molecular Biology
- Medicine and Medical Research