SAN DIEGO, Aug. 27 /PRNewswire-FirstCall/ -- Cardium Therapeutics today reported that a recent medical journal article highlights the challenges facing healthcare providers with respect to finding optimal treatments for patients with non-healing wounds.
As reported in the Journal of the American Academy of Physician Assistants, (JAAPA, August 2009), chronic wounds affect an estimated 5.7 million patients in the U.S. and cost the healthcare system approximately $20 billion annually. The article’s author further notes that optimal wound care requires a portfolio of treatments including the only FDA-approved protein-based topical gel Regranex(R) (becaplermin), bioengineered skin substitutes, hyperbaric oxygen therapy, and subatmospheric wound therapy (also known as negative-pressure wound therapy), as well as institutional support from the growing number of nationwide wound-care centers that offer specialized, multidisciplinary approaches to the treatment of chronic wounds. The author also reports that the cost of treating non-healing ulcers of longer than one year’s duration is estimated to range from approximately $20,000 to $27,000, based on the level of advanced care.
Innovative Advanced Care DNA-Based Therapy
Excellarate is an advanced care DNA-based biologic product candidate that is being developed to provide physicians and patients with a potentially simpler, easy-to-use treatment as compared to current therapies. Based on the positive data from a Phase1/2 study, the Company believes that the Excellarate topical gel provides a unique opportunity to: (1) improve patient compliance, based on a one or two physician administered treatment regimen, instead of current therapies which require multiple treatments by physicians or patients on a daily or weekly basis for up to 20 weeks, and (2) enhance acceptance by the medical community due to improved ease of use (as a pre-filled syringe, requiring only standard refrigeration and a 15-18 month shelf life), when compared to other treatment options.
Benchmarks with Current Therapy
Bioengineered Skin Substitutes - In addition to protein-based therapy, the JAAPA article discusses other advanced wound healing approaches for the treatment of diabetic foot ulcers that include bioengineered skin substitutes, as well as medical devices that provide negative pressure wound therapy. Bioengineered skin substitutes represent an important class of products that include two FDA-approved dermal graft substitutes: Apligraf(R) a combination of human fibroblasts and keratinocytes and Dermagraft(R), consisting of human fibroblasts alone. Based on product labeling and usage instructions, both products require multiple grafting procedures by physicians into the wound area (and may require the use of sutures) on a weekly or bi-weekly basis, by physicians over a 12-week period. Some products in this class require low temperature storage (-70 degrees Celsius) or need to be special ordered by a physician immediately prior to patient treatment because of a very limited shelf life (approximately 10 days).
Wound Care Centers - Chronic wounds represent a significant unmet medical need as evidenced by the emergence and growth of wound care centers across the U.S. These centers were developed by healthcare providers to provide specialized treatment to chronic wound patients. There are an estimated 1,000 outpatient wound care centers across the U.S. Wound care centers offer a broad spectrum of specialized care as well as best clinical practices for managing wound healing. Many centers provide hyperbaric oxygen therapy and most have access to a multidisciplinary medical team. Usually associated with a hospital, these centers provide a focused approach to wound management with the goal of reducing the need for inpatient care and surgical procedures such as amputation.
Market Opportunity and Pharmacoeconomics
Emerging trends in wound healing and a growing market demand are evidenced by the recent success of negative pressure wound therapy products, such as those marketed and sold in the U.S. by Kinetics Concepts Inc. and Smith & Nephew, representing the first $1.0 billion product segment in the wound care market. Based on these trends and needs, agents designed to accelerate the rate of wound healing are expected to play a more prominent role in the future of advanced wound care. As reported by MedTech Insight, the wound care market is projected to experience double digit growth over the next 3 to 5 years, with advanced wound care products comprising the fastest growing segment of the total wound care market. There are an estimated 91.3 million wounds in the U.S., which include 67.0 million surgical wounds, 17.6 million trauma wounds including burn injuries and amputations, 2.5 million pressure ulcers, 3.6 million diabetic ulcers and 3.3 million venous stasis and arterial ulcers. The ability to effectively address even a small proportion of these wounds would represent major new market opportunities for the Company’s Gene Activated Matrix (GAM) technology.
Earlier this week, Cardium announced that all patients enrolled in the Company’s MATRIX clinical study have completed their initial 12-week evaluation period and that it plans to provide detailed safety and efficacy data around the end of September 2009. The Phase 2b MATRIX clinical trial is a prospective, randomized, double-blind, placebo-controlled study of Excellarate for the potential treatment of chronic diabetic foot ulcers. This landmark gene therapy clinical study was designed to evaluate safety and efficacy in patients receiving the Excellarate drug candidate compared to placebo controls. A standard of care reference arm was also included in the study. The safety and key efficacy measures of the MATRIX study include complete wound closure, time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points, as well as other safety and healing metrics, which will be used to develop the planned Phase 3 clinical study. In addition, following the initial 12-week efficacy evaluation period, patients whose wounds have successfully closed will be followed for three months to further evaluate wound healing durability.
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Forward-Looking Statements
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, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, 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.
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