Phase I study of direct administration of a replication deficient adenovirus vector containing the vascular endothelial growth factor cDNA (CI-1023) to patients with claudication.

Publication Type	Academic Article
Authors	Rajagopalan S, Trachtenberg J, Mohler E, Olin J, McBride S, Pak R, Rasmussen H, Crystal R
Journal	Am J Cardiol
Volume	90
Issue	5
Pagination	512-6
Date Published	09/01/2002
ISSN	0002-9149
Keywords	Adenoviridae, DNA, Complementary, Endothelial Growth Factors, Genetic Vectors, Intermittent Claudication, Lymphokines, Virus Replication
Abstract	The long-term safety and efficacy of adenoviral delivery of growth factors in patients with peripheral arterial disease (PAD) is unknown. CI-1023 (Ad(GV)VEGF(121.10)) is a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121. In this phase I trial, we investigated the safety and efficacy of CI-1023 in subjects with advanced claudication symptoms secondary to infra-inguinal disease. Eighteen subjects >35 years of age with a median ankle brachial index (ABI) at rest of 0.525 (interquartile range 0.4) and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x10(8) to 4 x10(10) particle units, n = 15) or placebo (n = 3). Eleven of 15 patients (73%) who received CI-1023 and 1 of 3 subjects (33%) who received placebo, completed 1 year of follow-up. Edema and rash were the most common early adverse event. One infra-inguinal bypass procedure occurred in each of the placebo and CI-1023 groups at days 29 and 104, respectively. One death (day 160) and 1 malignancy (day 274) occurred in the CI-1023 group. Conclusions on efficacy could not be made due to the small number of patients. However, there were encouraging trends in ABI at rest and peak walking time at follow-up.
DOI	10.1016/s0002-9149(02)02524-9
PubMed ID	12208412