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Press Release: Phase 2b Clinical Trial of Excellarate(TM) for Diabetic Ulcers to Use OmniComm's First in Functionality(TM) Electronic Data Capture (EDC) Solution, TrialMaster(R)November 28, 2007: 09:30 AM EST
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OmniComm Systems, Inc. (OTCBB: OMCM), a leader in integrated electronic data capture (EDC) solutions for clinical trials, today announced that they will provide EDC services to Tissue Repair Company for a randomized, double-blind, placebo-controlled, comparator arm clinical trial 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 that is being developed to stimulate wound healing. The study is currently enrolling patients diagnosed with Type I or II diabetes with a non-healing foot ulcer present that has failed standard of care therapy. The study will enroll approximately 210 patients at 25 U.S. medical clinics.
"After successful completion of a Phase 1/2 clinical trial that proved Excellarate to be safe and well tolerated and resulted in a high rate of complete wound closure, we are excited to be underway with our Phase 2b study. We believe that Excellarate has the potential to be a best-in-class product compared to currently marketed products," said Barbara Sosnowski, Vice President of Operations for Tissue Repair Company. "We chose to use EDC and specifically TrialMaster in this study for the innate benefits that EDC provides such as ease of use, better access to the data, shorter study timelines and quicker study completion."
Cardium's Tissue Repair Company (TRC) subsidiary is focused on the development of growth factor therapeutics that promote tissue repair and regeneration. TRC's lead product candidate, Excellarate is being developed as a potential treatment of non-healing diabetic foot ulcers. The Excellarate topical gel uses TRC's Gene Activated Matrix(TM) (GAM) technology that is designed to provide localized and sustained cellular release of platelet-derived growth factor-BB protein.
"OmniComm is very proud to be chosen by Tissue Repair Company for this important diabetic wound healing trial. It gives us great satisfaction to know that Cardium and its subsidiaries recognize TrialMaster as a superior EDC solution for their trials," said Cornelis F. Wit, CEO of OmniComm. "The fact that Cardium chose us once again for EDC for their clinical trials proves that we are delivering on our promise to provide a product that is easy to use, flexible and cost effective along with the dedicated support services that our clients need and expect."
Re: Clinical Trial of Excellarate(TM) for Diabetic Ulcers
Here is a 2006 Press Release on this: CARDIUM ACQUIRES EXCELLARATE PRODUCT CANDIDATE FOR CHRONIC DIABETIC ULCERS AND RELATED TECHNOLOGY AND ASSETS FROM TISSUE REPAIR COMPANY
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SAN DIEGO, CA - August 14, 2006 - Cardium Therapeutics, Inc. (OTCBB: CDTP) today announced its acquisition of the wound healing technology and related assets of the Tissue Repair Company (TRC), a privately-held, San Diego-based company focused on the development of growth factor therapeutics for the potential treatment of tissue wounds such as dermal ulcers, which affect millions of diabetic patients. The assets acquired also include TRC technologies applicable to the treatment of ischemic heart disease.
In connection with this transaction, Cardium acquired TRC's lead product candidate, Excellarate™, a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-B (PDGF-B). Excellarate is initially being developed as a single administration for the treatment of non-healing, neuropathic diabetic foot ulcers. The Excellarate topical gel, a type of Gene Activated Matrix™, is designed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of chemotactic cells such as monocytes and fibroblasts, which are necessary for the stimulation of a variety of wound healing processes.
Excellarate has been evaluated in an initial multi-center Phase 1/2 clinical trial that evaluated preliminary safety and included an assessment of healing in 15 patients having diabetic foot ulcers that did not heal using conventional techniques. Based on the data obtained, Excellarate appeared to be safe and well tolerated in patients with diabetic foot ulcers. In addition, in the 12 patients that completed the treatment protocol and follow-up, over 80% of the patients exhibited complete closure of previously non-healing wounds by 14 weeks. Single dose applications were administered in 70% of the patients and the remaining patients received a weekly dose application over a four-week period. Based on the prior pre-clinical and toxicology database, and results from the Phase 1/2 clinical study, Cardium anticipates that Excellarate may be advanced into a randomized, double-blind, placebo-controlled, multi-center Phase 2b clinical study commencing in the latter half of next year.
Chronic wounds, such as diabetic ulcers, pressure ulcers, and venous stasis ulcers, cause significant morbidity in millions of patients each year in the United States. Individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy. According to the American Podiatric Medical Association, diabetic foot ulcer occurs in approximately 15 percent of patients with diabetes. Of those who develop foot ulcers, six percent will be hospitalized due to infection or other ulcer-related complications. Diabetes is the leading cause of non-traumatic lower extremity amputations and approximately 14 to 24 percent of patients with diabetes who develop foot ulcers have an amputation.
There are several treatment modalities currently used for severe chronic ulcers in diabetic patients, including topical dressings, off-loading, debridement and skin grafts. Regranex® Gel (becaplermin), which is marketed by Johnson & Johnson's Ethicon Wound Management Division, is considered to be the only FDA-approved prescription medicine to treat such wounds. Regranex® Gel is a recombinant human platelet-derived growth factor (rrPDGF-BB) protein that is used as an adjunct with other current treatment modalities described above and is used to treat lower extremity diabetic neuropathic ulcers. Based on Regranex® Gel's instructions for use, an estimated 70 administrations and 70 wound cleanings and redressings would be required over a 10-week treatment period (once daily administration followed by a subsequent wound cleaning and redressing without gel).
Cardium believes that patient compliance can be a major factor preventing or limiting improved medical outcomes, particularly when repeated administrations are required at a wound site. Excellarate is being developed as a next-generation treatment to leverage the established medical utility of PDGF-B, and to simplify treatment by stimulating the body's own localized and sustained production of PDGF-B at the wound site over a 6- to 12-week period following a single dose administration. Cardium believes that a one-time administration or in more severe cases several once-a-week administrations of the Excellarate topical gel, which is designed to mediate a sustained cellular-release of PDGF-B at the injury site, could substantially simplify the treatment regimen, thus potentially enhancing patient compliance and improving medical outcomes.
Re: Clinical Trial of Excellarate(TM) for Diabetic Ulcers
Press Release: The University Of Miami Is Enrolling Patients With Chronic Diabetic Foot Ulcers For MATRIX Clinical Trial
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The University of Miami Department of Dermatology announced it is recruiting patients with lower extremity diabetic foot ulcers to participate in the MATRIX clinical trial. The MATRIX trial will study the effects of Excellarate™ (GAM501) (Ad5PDGF-B/bovine Type I collagen gel) for the potential treatment of patients with neuropathic non-healing diabetic foot ulcers. Excellarate is an investigational product designed to stimulate the process of wound healing.
The MATRIX (A Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers in the Lower Extremities) trial is a randomized, double-blind, placebo-controlled, comparator arm (standard of care) safety and efficacy study to evaluate GAM501 (Ad5PDGF-B/bovine Type I collagen gel) that is topically administered once or twice over the course of the study. The primary endpoint will be the effect of Excellarate on the incidence of complete ulcer closure at 12 weeks or earlier.
"The Excellarate topical gel using Gene Activated Matrix (GAM) technology 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 chemotactic cells such as monocytes, fibroblasts, and endothelial cells, which are necessary for the stimulation of a variety of wound healing processes," stated Robert Kirsner, M.D., Ph.D., and a trial investigator.
Re: Clinical Trial of Excellarate(TM) for Diabetic Ulcers
Good to see at least one Podiatry Clinic is involved in this study:
Press Release: Diabetic Patients in Atlanta Recruited for Non-Healing Wound Clinical Trial
Jan 7 2008, 8:00 AM EST
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Village Podiatry Group is now recruiting diabetic patients for a new clinical research study in coordination with Cardium Therapeutics. The year long MATRIX clinical trial will study the effects of a new product, Excellarate, for the potential treatment of patients with non-healing diabetic wounds. The drug study is being conducted at Village Podiatry Group's Clinical Research Division in Smyrna, Georgia in the metro Atlanta region.
There are currently 20 million Americans who have diabetes and this number is expected to double by the year 2030. Over 850,000 chronic diabetic ulcers are diagnosed in the U.S. each year. Patients with non-healing ulcers are more susceptible to infections that may lead to amputation of the affected foot or leg.
The MATRIX trial is a randomized, double-blind safety and efficacy trial in which Excellarate is topically administered once or twice over the course of the study, with a goal of complete ulcer closure at 12 weeks or earlier. To qualify for the study, patients must be diagnosed with Type I or II Diabetes with a non-healing foot ulcer present for at least six weeks and who have failed standard of care therapy.
"The Excellarate topical gel, using Gene Activated Matrix (GAM) technology is designed to provide release of the platelet-derived growth factor BB protein, which stimulates the growth of new blood vessels and granulation tissue formation, the building blocks for a variety of wound healing processes," says the study's director, Brent Nixon, DPM.
Dr. Nixon is a practicing podiatric surgeon of more than 30 years and a certified clinical trial investigator. "Our goal as podiatrists is to heal ulcers before they develop into serious limb infections. We are very pleased to be part of this important study in the effort to increase the arsenal of effective medications for diabetic patients at risk of amputation," he states.
Village Podiatry Group is the largest podiatric surgical practice in the southeast. It was selected as the only MATRIX trial site in Georgia and among only 25 sites in the U.S. which includes Johns Hopkins Medical Center in Baltimore, MD and New York Presbyterian Hospital. Village Podiatry has 20 metro Atlanta locations. The MATRIX study is being conducted at the group's Clinical Research Division in Smyrna at 3969 South Cobb Drive, Suite 102. Prospective participants should call 770-319-5502 for more information about the study and potential eligibility.
Re: Clinical Trial of Excellarate(TM) for Diabetic Ulcers
Press Release: Cardium Announces Completion Of Patient Recruitment In Phase 2b Clinical Trial Of Excellarate(TM) For The Potential Treatment Of Diabetic Foot Ulcers
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Cardium Therapeutics (NYSE Amex: CXM) and its subsidiary Tissue Repair Company (TRC) announced the completion of recruitment for the pioneering Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of the Excellarate(TM) product candidate for the potential treatment of non-healing foot ulcers in patients with type I or type II diabetes. Excellarate is designed to require only one or two physician-administered treatments, in contrast to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months).
Excellarate is a collagen-based topical gel employing TRC's Gene Activated Matrix(TM) (GAM) technology to locally stimulate the release of platelet-derived growth factor-B protein (PDGF-B), an important key in the human body's wound healing process. Sustained, localized micro-release of PDGF-B by a patient's own cells 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. These cell types are critical for the effective stimulation of a variety of wound healing processes.
MATRIX Study Completion and Plans
The MATRIX 2b clinical trial which has now completed recruitment is a prospective, randomized, double-blind, placebo-controlled study that screened approximately 285 patients at 30 U.S. medical centers and recruited more than 120 patients with lower extremity neuropathic ulcers that were chronically non-healing despite receiving standard of care. The study is designed to evaluate safety and efficacy in patients receiving one or two doses of Excellarate compared to placebo controls. A standard of care reference arm is also included in the study. The primary endpoint of the study is complete wound closure at or before the initial 12-week study period. Other key efficacy endpoints include time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points. With confirmation of one or more medically meaningful responses, Cardium and TRC would expect to meet with the U.S. Food and Drug Administration (FDA) to review the complete safety and efficacy database from this Phase 2b clinical study and their plans for initiating a larger-scale Phase 3 pivotal study.
The MATRIX clinical study demographics appeared to be well balanced and reflective of the patient population Excellarate would be intended to treat. Based on the data from patients enrolled in the study, the mean size of ulcers at treatment was approximately 2.9 cm2 (range ~1.4 - 9.0 cm2), and these ulcers were considered chronic, having remained unhealed prior to treatment for a median of approximately 30 weeks (range ~6 - 678 weeks). The median age of patients enrolled in the study was approximately 60 (range 31 - 86). Approximately three quarters of the patients were men and one quarter were women; and they represented a range of racial and ethnic backgrounds.
All patients in the MATRIX study also underwent an initial two-week pre-treatment with standard of care therapy in order to confirm that the wounds to be treated in the study were chronic and non-healing. It was found that approximately 27% of the patients in the study had previously had at least one amputation (either a toe or a complete foot) due to prior unhealed ulcers. In addition, approximately 14% of the wounds being treated in the study had previously failed to heal even after being treated with what are generally regarded as the most advanced wound care procedures available (i.e., repeat-administration therapies using Becaplermin protein [Regranex(R)] or negative pressure pumps, or "living-skin" equivalents).
The MATRIX Data and Safety Monitoring Board has reviewed safety data collected for study participants as of April 21, 2009 and reported that the Excellarate product candidate appeared to be both safe and well tolerated, with no serious adverse events attributable to the study product. The Company will report further on safety and key efficacy data - particularly the percentage of patients achieving complete wound closure, the rate of wound closure and the reduction of wound size at various time points - when such data become available. Patients whose wounds are successfully closed are also followed for several months to verify that their wounds remain closed.
Approximately 70% of the patients recruited in the MATRIX study have already completed their initial 12-week evaluation period. Consistent with other Phase 2 clinical study designs, the MATRIX clinical trial is powered to demonstrate a statistically significant difference between patients treated with the Excellarate drug candidate (one or two doses as a single group) compared to placebo treated patients based on an 80% statistical powering and a 95% confidence interval.
The ability to achieve closure of chronically non-healing wounds following application of a simple topical gel is considered to be particularly important in patient populations such as diabetics among others, for whom compliance with a regimen of repeated wound cleanings and product re-administrations can pose a major limitation affecting the use and therapeutic effectiveness of available products. In addition, many patients, including approximately one in seven participants in the MATRIX clinical study, have wounds that did not close even after treatments with what are regarded as the most advanced wound care therapies currently available. Failure to close these chronic diabetic wounds is associated with a continuing risk of infections leading to amputation, a result that is associated with extremely high mortality (approximately 50% of such patients die within three years following amputation).
"Our pioneering Excellarate product candidate, which is driven by TRC's Gene-Activated Matrix technology platform, is being developed to address a number of therapeutic and administration limitations of existing drugs and other currently available therapies for diabetic patients suffering with chronic foot ulcers," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium. "Our MATRIX clinical study, which included extensive photographic documentation, as well as computerized ulcer planimetry measurements on a weekly basis, represents one of the most extensively evaluated DNA-based wound healing therapeutics ever developed. The valuable information from this study is also expected to support Cardium and TRC advancing into other important product opportunities including pressure ulcers, venous stasis ulcers, bone injury repair and potentially other advanced therapeutic applications."
Clinical Trial of Excellarate(TM) for Diabetic Ulcers
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