SAN DIEGO, May 27 /PRNewswire-FirstCall/ -- Cardium Therapeutics and its subsidiary, Tissue Repair Company (TRC) today announced the launch of a new website at http://www.diabeticfootstudy.com to provide patients, caregivers and physicians with information about the Company’s Phase 2B MATRIX clinical study. The MATRIX study is evaluating the safety and efficacy of Excellarate(TM) for the potential treatment of non-healing diabetic foot ulcers. Excellarate is a DNA-based topical gel that is designed to stimulate wound healing in one or two physician-administered applications.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO )
The MATRIX clinical study has also been the focus of media attention in multiple regions across the U.S., including television news features in Florida, Texas, Pennsylvania, Arizona, Maryland, North Carolina and Southern California. To view newspaper articles and the television video clips of the recent media coverage, please visit http://www.cardiumthx.com/flash/videos.html.
MATRIX Study and Currently Participating Clinical Sites
The MATRIX study (GAM501 for the Treatment of Diabetic Ulcers in the Lower Extremities), a randomized, double-blind, placebo-controlled, comparator arm clinical trial, is expected to enroll approximately 210 patients at up to 40 U.S. sites. The study is enrolling patients diagnosed with Type I or II diabetes with a non-healing foot ulcer that has been present for at least six weeks and who have failed standard of care therapy. The five arms of the study include standardized 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 are time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and tolerance.
Currently, there are 31 MATRIX sites across the nation, and the Company expects to increase the number of sites to 40 U.S. sites over the next two months. Participating sites include: Aung Foothealth Clinics (Tucson, AZ); Banner Baywood Medical Center (Mesa, AZ); Associated Foot & Ankle Specialists (Phoenix, AZ); Southern California Institute for Research and Education, VA Medical Center (Long Beach, CA); LAC-USC Medical Center (Los Angeles, CA); Roy Kroeker DPM (Fresno, CA); Johns Hopkins Medical Center (Baltimore, MD), North American Center for Limb Preservation (New Haven, CT); University of Miami (Miami, FL); Bay Pines VAHCS (Bay Pines, FL); Mount Sinai School of Medicine (New York, NY); Village Podiatry Group (Smyrna, GA); Memorial Hospital (Belleville, IL); Boston Medical Center, (Boston, MA); New York University (New York, NY); Stony Brook University Medical Center (Stony Brook, NY), University of North Carolina (Chapel Hill, NC); Warren General Hospital (Warren, PA); University of Texas Medical Branch (Galveston, TX); St. Joseph Medical Center (Houston, TX); South Texas Foot Institute (San Antonio, TX), Foot Doctors of Watsonville (Watsonville, CA), Advanced Foot and Ankle Center (Las Vegas, NV), Karr Foot Kare (Lakeland, FL), Lehigh Valley Hospital (Allentown, PA), Absolute Foot Care (Chula Vista, CA), Jagpreet Mukker, DPM (Fresno, CA), St. Vincent Wound Center (Little Rock, AR), Presbyterian Hospital of Dallas (Dallas, TX), Baptist Medical Center South (Montgomery, AL), Olive View-UCLA (Sylmar, CA).
Excellarate and Tissue Repair Company’s GAM Technology
The Excellarate topical gel employs TRC’s Gene Activated Matrix(TM) technology and is designed to provide localized 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.
Gene Activated Matrix(TM) (GAM) technology is designed to provide a therapeutic level of protein synthesis at a particular site in the body and can be used in soft tissue such as skin, ligament, tendons and cartilage, as well as hard tissue such as bone. The technology is distinctive in that it is an immobilized form of local gene delivery that allows for control of gene dispersion. GAM consists of a biocompatible matrix comprising a gene or DNA vector encoding a growth factor or other therapeutic protein. For tissue repair, the application method involves placement of a GAM gel directly onto a wound site. TRC’s studies have shown that proliferative cells in the body can migrate into the GAM, take up the immobilized vector and gene and then transiently express the encoded therapeutic protein. Compared with topical applications of proteins, this in situ expression method significantly prolongs the local availability of therapeutic protein to the cells involved in tissue repair. TRC’s GAM technology may have potential utility in several clinical indications where protein therapeutics have had limited success, including treatment of dermal wounds (such as diabetic foot ulcers), therapeutic angiogenesis (pharmacologically inducing new blood vessel growth), and orthopedic products for repair of various tissues, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage).
About Cardium
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies, Inc. and the Tissue Repair Company, are medical technology companies primarily focused on the development, manufacture and sale of innovative therapeutic products and devices for cardiovascular, ischemic and related indications. Cardium’s lead product candidate, Generx(TM) (alferminogene tadenovec, Ad5FGF4), is a DNA-based growth factor therapeutic being developed for potential use by interventional cardiologists as a one-time treatment to promote and stimulate the growth of collateral circulation in the hearts of patients with ischemic conditions such as recurrent angina. For more information about Cardium and its businesses, products and therapeutic candidates, please visit http://www.cardiumthx.com or view its 2007 Annual Report at http://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
Cardium’s InnerCool Therapies subsidiary is a San Diego-based medical technology company in the emerging field of patient temperature modulation therapy to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes. For more information about Cardium’s InnerCool subsidiary, including InnerCool’s Celsius Control System(TM) and CoolBlue(TM) patient modulation system, please visit http://www.innercool.com.
Cardium’s Tissue Repair Company subsidiary (TRC) is a San Diego-based biopharmaceutical company focused on the development of growth factor therapeutics for the treatment of severe chronic diabetic wounds. TRC’s lead product candidate, Excellarate(TM), is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-BB (PDGF-BB). Excellarate is initially being developed to be administered once or twice for the potential treatment of non-healing diabetic foot ulcers. Other potential applications for TRC’s Gene Activated Matrix(TM) (GAM(TM)) technology include therapeutic angiogenesis (cardiovascular ischemia, peripheral arterial disease) and orthopedic products, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage) repair. For more information about Cardium’s Tissue Repair Company subsidiary, please visit http://www.t-r-co.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results or trends observed in one clinical study will be reproduced in subsequent studies, that our clinical trials can be initiated and conducted in a timely and effective manner, that necessary regulatory approvals will be obtained, that our actual or proposed products and treatments will prove to be sufficiently safe and effective, that competing products will not be safer, more effective or less expensive, that third parties on whom we depend will perform as anticipated, or that our products or product candidates will lead to value enhancing or partnering opportunities. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development, testing and marketing of therapeutic product candidates, risks and uncertainties that are inherent in the conduct of human clinical trials, including the cost, timing and results of such trials, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2008 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com.
Cardium Therapeutics(TM) and Generx(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM) and Excellarate are trademarks of Tissue Repair Company.
InnerCool Therapies(R), InnerCool(R), Celsius Control System(TM), CoolBlue(TM), RapidBlue(TM) and Accutrol(TM) are trademarks of InnerCool Therapies, Inc.
CONTACT: Bonnie Ortega, Director, Investor|Public Relations, Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web site: http://www.cardiumthx.com/
http://www.t-r-co.com/
http://www.innercool.com/
http://www.diabeticfootstudy.com/
