Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

Cardium begins Phase 2b Excellarate clinical study for diabetic ulcers

Cardium Therapeutics : 14 November, 2007  (New Product)
Cardium Therapeutics and its subsidiary, Tissue Repair Company (TRC) announced the start of recruitment for its Phase 2b clinical trial (Matrix) to evaluate the safety and efficacy of Excellarate for the potential treatment of non-healing diabetic foot ulcers.
Excellarate is a DNA-based topical gel for administration once or twice to stimulate wound healing.

The Matrix study (GAM501 for the Treatment of Diabetic Ulcers in the Lower Extremities), a randomised, double-blind, placebo-controlled, comparator arm clinical trial is expected to enroll approximately 210 patients at about 25 US sites.

The study will enroll patients diagnosed with Type I or II diabetes with a non-healing foot ulcer present that have been present for at least six weeks and who have failed standard of care therapy. The five arms of the study will include standardised care, consisting of surgical debridement, dressing changes, and weight off-loading devices, one or two applications of placebo, and one or two applications of Excellarate.

The study's primary endpoint is complete ulcer closure at 12 weeks or earlier. Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and tolerance.

'We believe that Cardium's Excellarate topical gel product candidate, which is being developed as a physician-administered one or two-time treatment for diabetic patients with chronic, non-healing lower extremity ulcers, has the potential to be a best-of-class product compared to currently marketed products, products under development and other adjunctive therapies, including relatively expensive negative pressure pump systems and hyperbaric chamber therapies, which generally require daily treatments over extended periods of time. With our Matrix clinical trial now underway, we expect to complete the study within approximately 12 months,' stated Christopher J Reinhard, chairman and chief executive officer of Cardium.

The Excellarate topical gel employs TRC's Gene Activated Matrix technology and is designed to provide localised and sustained cellular release of platelet-derived growth factor-BB protein (PDGF-BB). Sustained delivery of PDGF-BB directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts and endothelial cells, which are necessary for the stimulation of a variety of wound healing processes. A previous Phase 1/2 clinical trial showed that Excellarate appeared to be safe and well-tolerated and resulted in a high rate of complete wound closure.
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo