Cardium's Gene Activated Matrix technology demonstrates benefits in periodontal tissue regeneration

www.cardiumthx.comSep 15 2009

Cardium Therapeutics (NYSE Amex: CXM) today reported on preclinical findings published in the scientific journal, Gene Therapy, demonstrating that Cardium's Gene Activated Matrix(TM) or GAM(TM) technology accelerates periodontal tissue regeneration of oral implant-supporting wounds. The PDGF-B gene therapy accelerates bone engineering and oral implant osseointegration study (Chang, et al., Gene Therapy; 10 September 2009; doi: 10.1038/gt.2009.117) conducted by researchers at the University of Michigan is available online at nature.com/doifinder/10.1038/gt.2009.117, and reports on the use of AdPDGF-B/collagen (the key component of the Company's Excellarate(TM) product candidate) to promote oral implant osseointegration. The study's findings demonstrate that AdPDGF-B/collagen is safe, accelerates and enhances oral implant osseointegration, and leads to significantly higher bone-implant contact, defect fill, bone area and tissue mineral density than placebo.

Oral implants are widely accepted in dental medicine as a reconstructive treatment for tooth replacement due to disease, injury or congenital defects. Growth factor application has been advocated to improve osteogenesis and osseointegration, however, as a result of the transient action and short half-life of proteins, the sustained bioavailability associated with growth factor gene delivery has been proposed as an effective alternative for the delivery of growth factor proteins. The preclinical study demonstrated that the initial response to a bolus administration of rhPDGF-BB protein was strong, but the short half-life of the protein results in rapid degradation with a decrease in the mitogenic response. In contrast, PDGF-B gene delivery using Cardium's Gene Activated Matrix technology resulted in sustained protein expression that lasted for approximately 14 days. The benefits of this prolonged availability are expected to be even more evident in planned large animal critical size defect models. The study also reported that there was no dissemination of the AdPDGF-B vector away from the treatment site, and no alteration of hematological and clinical chemistry parameters associated with the AdPDGF-B/collagen treatments. The authors conclude that, "This approach shows the ability of Ad-PDGF-B to accelerate oral implant osseointegration. The data support the concept that Ad-PDGF-B gene delivery may be an effective and safe mode of therapy comparable with PDGF-BB application to promote dental implant osseointegration and oral bone repair."

"The results of this preclinical study demonstrate the potential benefits of our GAM technology for bone engineering and oral implant osseointegration and further support our decision to expand the focus of the Company's regenerative medicine technologies to include orthobiologics," reported Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and Tissue Repair Company. "Cardium's Gene Activated Matrix technology and protein-producing gene portfolio are important building blocks as we expand our product development programs from wound healing biologics into the emerging new high growth market segment of orthobiologics."