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Product Programs
Dermal Ulcers
The initial indication for Tissue Repair Company is chronic lower extremity ulcers in diabetics. TRC is currently recruiting patients for its Phase 2b Excellarate MATRIX clinical study for chronic diabetic foot ulcers.
The wound care marketplace in the U.S. is significant. Over 3.8 million cases of chronic, slow-healing or non-healing dermal ulcers are treated in the U.S. each year. In these wounds, the skin breaks down as a result of disruption of blood flow caused either by prolonged pressure over a localized area or by chronic diseases (i.e. diabetes). In many of these patients, dermal ulcers are open wounds, which are resistant to healing for many months or years.
Currently, there are 21 million people (7% of the U.S. population) that have diabetes. Every day approximately 3,450 new cases are diagnosed, and an estimated 1,200,000 new cases are identified each year. Fifteen percent (3.15 million) of patients affected with diabetes will develop foot related ulcers. Ulcers that do not heal leave the patients susceptible to infection and may lead to amputation of the foot or leg. It is known that diabetes is the leading cause of lower extremity amputations with 5 to 15 % requiring an amputation at some time in their lives. The three-year survival rate following amputation is only 50%.
In part because current therapies for skin ulcers are often ineffective, the treatment is an expensive process. Individual patient treatment can cost thousands of dollars per year. Published sources estimate that the U.S. healthcare system spends more than $5 billion each year for the treatment of chronic dermal wounds. With the increase in number of diabetics, the aged and obese populations in the U.S. the number of chronic wounds and their associated costs will increase dramatically in the near future.
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EXCELLARATE
TRC’s lead product candidate, EXCELLARATE, is a proprietary DNA-based, collagen matrix gel for topical treatment formulated with an adenovector carrier that encodes for human Platelet-Derived Growth Factor-B (PDGF-B). EXCELLARATE has been studied in an initial multi-center Phase 1/2 clinical trial that evaluated preliminary safety and included an assessment of healing. Based on the data from this 12-patient study, Excellarate appeared to be safe and well tolerated with over 80% of patients showing complete wound closure by 14 weeks based on a single dose or a single weekly dose application over a four-week period.
Patient #1: This patient is a 49-year old male with a medical history of hypertension, type II diabetes mellitus, inability to perceive 10 gm monofilament device in all quadrants, bilateral feet and lower extremities, right plantar great toe ulcer, and lower extremity edema. Ulcer-related treatment history included sharp debridement, enzymatic debriders and wound vacuum devices. The patient presented with a Grade 1, plantar ulcer measuring 2.5 cm x 2.3 cm on the right foot, great toe that had been unsuccessfully treated for 36 months prior to enrolling in the Excellarate Phase 1/2 clinical study. This patient was scheduled for amputation of his great toe due to failure of healing. He was treated with 4 applications of the mid-dose Excellarate given on a weekly basis. The patient’s ulcer healed 8 weeks after the fourth application of the drug.
Before Treatment
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After Treatment (12 weeks) -
Patient #2: This patient is a 46-year old male with a medical history of peripheral neuropathy, right foot dorsal ulcer, and type II diabetes mellitus. Prior ulcer-related surgical history included incision and debridement. Ulcer-related treatment history includes Neosporin, wet to dry dressings (standard of care), and enzymatic debrider. The patient presented with a Grade 1, dorsal ulcer measuring 6.0 cm x 1.2 cm on the right foot and had been unsuccessfully treated for approximately 6 months before enrolling in the Excellarate Phase 1/2 clinical study. He was treated with 4 applications of Excellarate given on a weekly basis. The patient’s ulcer healed 8 weeks after the fourth application of the drug.
Before Treatment -
After Treatment (11 weeks) -
Patient #3: This subject is a 58-year old male with a medical history of bilateral foot neuropathy and right hand neuropathy, hypertension, coronary artery disease, atrial fibrillation, sick sinus syndrome, and peripheral vascular disease, claudication R>L, diabetes mellitus type II, hyperlipidemia, azotemia, and fifth metatarsal left foot plantar medial ulcer. Prior ulcer-related surgical history included amputation left fourth toe. Ulcer-related treatment history includes silver treated gauzes, ointment and antibiotics. This patient presented with a Grade 1, plantar medial ulcer measuring 1.2 cm x 1.2 cm on the left foot and had been unsuccessfully treated for approximately 6 months before enrolling in the Excellarate Phase 1/2 clinical study. He was treated with a single application of Excellarate. The patient’s ulcer healed 13 weeks after application of the drug.
Before Treatment -
After Treatment (13 weeks) -
Given these favorable Phase 1/2 results, Tissue Repair Company is preparing to initiate a Phase 2, placebo-controlled efficacy study of EXCELLARATE in diabetic ulcers by the first quarter of 2008.
Venous Stasis Ulcers
Each year, approximately 1 million people in the U.S. are treated for venous stasis ulcers. Venous stasis ulcers result when damage to the valves of the deep leg veins reduces the ability to return blood to the upper body, leading to pooling of blood in the legs and subsequent breakdown of the skin. Venous stasis ulcers that do not respond to medical treatment often must be closed surgically by the use of skin grafts. These wounds are extremely difficult to heal using conventional therapeutic modalities.
Pressure Ulcers
There are an estimated 2 million acute and chronic pressure ulcers in the U.S. representing the largest market segment for wound care and replacement products. Pressure ulcers, also known as decubitus ulcers or bedsores, form when the skin and underlying tissue are under pressure without movement to promote blood flow. Any area of tissue that lies just over a bone is very likely to form a decubitus ulcer. This occurs most often in people who are bed-ridden and cannot change positions frequently, such as paraplegics or the immobile elderly. With the elderly population increasing at a rapid rate, the market for treating pressure ulcers is projected to grow the fastest of the three main ulcer categories, because it is the one most closely correlated with age.
Tissue Repair Company plans to conduct Phase II efficacy studies using EXCELLARATE for the treatment of pressure ulcers by leveraging the safety data generated from the Phase I diabetic ulcer study.
For information about our clinical trials:
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