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Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): results of a phase 1/2 trial.

Abstract
The results from a Phase 1/2 study of a replication-defective adenovirus encoding human platelet-derived growth factor (PDGF)-B formulated in a bovine collagen (Ad-5PDGF-B; 2.6% collagen; GAM501) gel for nonhealing neuropathic diabetic foot ulcers is reported. The primary objectives of the study were to evaluate the safety, maximum-tolerated dose, and preliminary biological activity of GAM501. Fifteen patients enrolled into the study with chronic, nonhealing ulcers received either a single administration of GAM501 at one of three dose levels, or up to four administrations of GAM501 at 1-week intervals. All patients received standard of care treatment including debridement and were required to wear an off-loading shoe. GAM501 was found to be safe and well tolerated with no evidence of systemic or local toxicity at all doses so no maximum-tolerated dose was reached. Serum antibody titers to platelet-derived growth factor-B homodimer and collagen were negative and adenoviral DNA was not detected in the blood. In the 12 patients that completed the study, ulcer closure was observed by Month 3 in 10 patients, seven of whom received a single application of GAM501. In conclusion, GAM501 did not appear to have any toxicity at doses that showed biological activity. GAM501 holds promise as a potentially effective treatment for nonhealing diabetic foot ulcers.
AuthorsGerit Mulder, Arthur J Tallis, V Tracy Marshall, David Mozingo, Laurie Phillips, Glenn F Pierce, Lois A Chandler, Barbara K Sosnowski
JournalWound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society (Wound Repair Regen) 2009 Nov-Dec Vol. 17 Issue 6 Pg. 772-9 ISSN: 1524-475X [Electronic] United States
PMID19821960 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)
Chemical References
  • Gels
  • Proto-Oncogene Proteins c-sis
Topics
  • Adenoviruses, Human (genetics, immunology)
  • Administration, Topical
  • Adult
  • Aged
  • Bandages, Hydrocolloid
  • Debridement
  • Diabetic Foot (drug therapy, surgery)
  • Drug Dosage Calculations
  • Female
  • Gels
  • Genetic Therapy
  • Humans
  • Male
  • Middle Aged
  • Proto-Oncogene Proteins c-sis (administration & dosage, adverse effects, genetics)
  • Wound Healing

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