Cardium Therapeutics (AMEX:CXM) 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(TM) for the potential treatment of
non-healing diabetic foot ulcers. Excellarate is a DNA-based topical
gel that is being developed to be administered once or twice to
stimulate wound healing.
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 about 25 U.S. 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 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 will be time to complete
ulcer closure, change in ulcer area, durability of wound closure, and
safety and tolerance. Enrollment criteria, participating sites and
other information about the MATRIX trial can be found
here.
"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(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.
Currently Participating MATRIX Clinical Sites
Clinical sites participating in the MATRIX study include: Mount
Sinai School of Medicine (New York, NY); 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); Northern California Foot/Ankle Center (Santa Rosa, CA); LAC-USC
Medical Center (Los Angeles, CA); Dr. Roy Kroeker
DPM (Fresno, CA); Johns Hopkins Medical Center (Baltimore, MD), North
American Center for Limb Preservation (New Haven, CT); Doctor's
Research Network (Miami, FL); University of Miami (Miami, FL); Bay
Pines VAHCS (Bay Pines, FL); Village Podiatry Group (Smyrna, GA);
Memorial Hospital (Belleville, IL); New York Presbyterian
Hospital (New York, NY); Stony Brook University Medical Center (Stony
Brook, NY), University of North Carolina (Chapel Hill, NC); and Warren
General Hospital (Warren, PA).
GAM Technology
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 (alferminogene tadenovec, Ad5FGF-4), 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 Therapeutics and its businesses, products and
therapeutic candidates, please visit cardiumthx or view its
recent
2006 Annual Report.
Cardium's InnerCool Therapies subsidiary is a San Diego-based
medical technology company in the emerging field of temperature
modulation therapy which is designed 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
and therapeutic hypothermia, including InnerCool's Celsius Control
System(TM), which has received regulatory clearance in the U.S.,
Europe and Australia, please visit innercool.
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, 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. Excellarate will be evaluated in a Phase 2b
study (MATRIX) which is expected to commence in the third quarter
2007. Other potential applications for TRC's Gene Activated Matrix(TM)
(GAM) 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 t-r-co.
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
clinical trials and other efforts to accelerate the development of our
Excellarate(TM) product candidate will be successful, 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 2007 Cardium Therapeutics, Inc. All rights reserved.
cardiumthx