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Phase I/II trial of intravenous OV001 oncolytic virus in resistant glioblastoma multiforme (GBM)


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://meeting.jco.org/cgi/content/abstract/22/14_suppl/1515

Posted on: 10/03/2004

Phase I/II trial of intravenous OV001 oncolytic virus in resistant glioblastoma multiforme (GBM)

Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).

Vol 22, No 14S (July 15 Supplement), 2004: 1515

© 2004 American Society of Clinical Oncology



Abstract

A. I. Freeman, J. M. Gomori, E. Linetsky, Z. Zakay-Rones, A. Panet, E. Libson, C. S. Irving, E. Galun and T. Siegal

Hadassah University Hospital, Jerusalem, Israel; Hebrew University, Jerusalem, Israel; OVCure (Israel) Ltd, Jerusalem, Israel; Savad Institute of Gene Therapy Hadassah Hospital, Jerusalem, Israel; Gaffin Center for Neuro-Oncology Hadassah Hospital, Jerusalem, Israel

1515

Background: OV001 (NDV HUJ) is an oncolytic, non-engineered, lentogenic strain of Newcastle Disease Virus (NDV). Following preclinical repetitive dosing toxicity studies, a Phase I/II trial was initiated in GBM determining safety and imaging response. Methods: Patients (11–58yrs, KPS 50–90%) with primary glioblastoma were enrolled 17–49 wks following diagnosis and failure of previous therapy. The first part of the study used an intra-patient dose escalation method with one cycle dosage steps of 0.1, 0.5, 1, 5 and 10 BIU units of OV001 (1 BIU = 1x109 EID50, 50% egg infectious dose). One cycle consisted of 15 min IV infusions on each of 5 consecutive days over a period of 7 d (<1BIU) or 14 d (>=1BIU). Patient reaching 10 BIU received 3 additional cycles of 50 BIU. Patients enrolled in the second part received three cycles of 10 BIU. Patients without progressive disease were maintained with 2 doses of 10 BIU IV weekly.

Results: In Phase I, 4/6 patients completed all 3 cycles of 50 BIU of OV001; in the Phase II part, as of Dec 01, 2003, 3/4 patients in Phase II part completed all 3 cycles of 10 BIU. Grade I/II constitutional fever was seen in 5 patients and was the only adverse event related to OV001 administration. MTD was not reached. Patients that did not complete dosing were withdrawn due to disease progression. All tested patients developed anti-NDV hemagglutinin antibodies after 7–14 days. NDV was recovered from one tumor biopsy. One patient has a continuing near complete response 30 weeks after start of dosing. A second patient maintained stable disease between 16–26 weeks.

Conclusions: Intravenous OV001 is well tolerated and most excitingly a near complete response provides proof of concept of its therapeutic potential.




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