A Randomized, Double-Blind, Placebo-Controlled, Single- and Double-Dose, Comparator Arm (Standard of Care), Multicenter Phase 2b Study of Topical GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in the Treatment of Non-Healing Diabetic Ulcers of the Lower Extremities

This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in subjects ≥ 18 years old with non-healing diabetic foot ulcers. Approximately 210 adult subjects with Type I or Type II diabetes mellitus will be enrolled at approximately 30 investigational sites in the United States.

Start Date01 Nov 2007

Sponsor / Collaborator

Tissue Repair Co.

[+1]

100 Clinical Results associated with GAM-501

100 Translational Medicine associated with GAM-501

100 Patents (Medical) associated with GAM-501

Literatures (Medical) associated with GAM-501

01 May 2011·Wound Repair and RegenerationQ3 · MEDICINE

Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers

Q3 · MEDICINE

Article

Author: Robert S. Kirsner ; Lois A. Chandler ; Arthur J. Tallis ; Vickie R. Driver ; Cyaandi Dove ; Soma Wali ; Peter Blume ; Robert L. Engler ; Barbara K. Sosnowski ; William Marston ; Wyatt G. Payne ; Roy Kroeker

ABSTRACTWe assessed the safety and efficacy of Formulated Collagen Gel (FCG) alone and with Ad5PDGF‐B (GAM501) compared with Standard of Care (SOC) in patients with 1.5–10.0 cm2 chronic diabetic neuropathic foot ulcers that healed <30% during Run‐in. Wound size was assessed by planimetry of acetate tracings and photographs in 124 patients. Comparison of data sets revealed that acetate tracings frequently overestimated areas at some sites. For per‐protocol analysis, 113 patients qualified using acetate tracings but only 82 qualified using photographs. Prior animal studies suggested that collagen alone would have little effect on healing and would serve as a negative control. Surprisingly trends for increased incidence of complete closure were observed for both GAM501 (41%) and FCG (45%) vs. Standard of Care (31%). By photographic data, Standard of Care had no significant effect on change in wound radius (mm/week) from during Run‐in to Week 1 (−0.06±0.32 to 0.78±1.53, p=ns) but both FCG (−0.08±0.61 to 1.97±1.77, p<0.002) and GAM501 (−0.02±0.58 to 1.46±1.37, p<0.002) significantly increased healing rates that gradually declined over subsequent weeks. Both GAM501 and FCG appeared to be safe and well tolerated, and alternate dosing schedules hold promise to improve overall complete wound closure in adequately powered trials.

01 Nov 2009·Wound Repair and RegenerationQ3 · MEDICINE

Treatment of nonhealing diabetic foot ulcers with a platelet‐derived growth factor gene‐activated matrix (GAM501): Results of a Phase 1/2 trial

Q3 · MEDICINE

Article

Author: Arthur J. Tallis ; Glenn F. Pierce ; Barbara K. Sosnowski ; V. Tracy Marshall ; David Mozingo ; Laurie Phillips ; Gerit Mulder ; Lois A. Chandler

ABSTRACTThe 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.

100 Deals associated with GAM-501

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic Foot	Phase 2	US	Taxus Cardium Pharmaceuticals Group, Inc.	01 Nov 2007

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