Dermal Wound Healing

Wounds fall into several categories depending on whether they are chronic or acute, or result from disease, the environment, accidents, or medical procedures. The elderly, diabetics, immunosuppressed and immobilized individuals have an increased incidence of chronic wounds and other dermal afflictions that result from poor circulation and immobility, e.g., pressure ulcers (bed sores), venous stasis ulcers, and diabetic ulcers.

These chronic conditions greatly increase the cost of care and reduce the patient’s quality of life. The cost of treating all chronic wounds is estimated at over $8 billion per year and is expected to increase 10% annually. An aging population will see an increase in bedridden patients whose frail skin is resistant to healing. Additionally, the incidence of obesity, which leads to diabetes, is on the rise. It is estimated that of the 14 million diabetics in the United States, some 1.5 million suffer from impaired healing problems. According to the Centers for Medicare & Medicaid Services (CMS), the number of lower-extremity, diabetes-related amputations has risen from 56,000 in 1994 to 87,000 in 2000.

The incidence of pressure ulcers is even greater with 5 million in the acute care setting, 1.25 million in the long-term health care setting, and 1.1 million in the home health care setting. The cost of treating a pressure ulcer can be as high as $50,000 per patient and require several months or even years to heal.

In summary, the aging population and the increase in diabetes suggest a growing need for new products to treat these patient populations and, therefore, a significant market opportunity exists. RegeneRx has identified these potential dermal wound healing markets for Tß4 and is sponsoring three Phase II clinical trials.

Cardiovascular and Neurovascular Wound Healing

A key scientific paper published in Nature in November, 2004, indicated that Tβ4 helped prevent or immediately repaired damage to the heart after an ischemic heart attack in laboratory animals. A second Nature paper, published in January, 2007, elaborated on this study and found that Tβ4 stimulated adult epicardial stem cells to differentiate into new cardiac vessels. These mechanisms of action, while not completely understood, may have applications for neurovascular or other ischemic injuries. Tβ4’s ability to prevent cardiac cell apoptosis (programmed cell death) during a heart attack appears to replicate Tβ4’s ability to prevent apoptosis in the cornea.

Heart attacks occur in a million people annually in the U.S. and 13+ million suffer from coronary artery disease. Heart attacks are the single largest cause of death in the U.S. and result in $250 billion in direct costs per year. Reperfusion (restoring blood flow by opening a blocked artery and a common cardiovascular procedure) can cause significant heart damage as well.

Strokes occur in over 700,000 people annually in the U.S. and are the 3rd leading cause of death and leading cause of disability among adults. Strokes result in $54 billion in direct and indirect costs per year in the U.S.

There is tremendous need for more effective and affordable therapeutics to prevent or repair damage resulting from heart attack and stroke. Such products would undoubtedly enjoy significant market acceptance by physicians, patients, and insurers while being especially attractive to major pharmaceutical companies seeking to fill their pipelines with new and improved medical products.

Ophthalmic Wound Healing

There are numerous opportunities for an ophthalmic wound healing product. For example, people with diabetes often have difficulty healing after ophthalmic surgeries, such as vitrectomy. Injuries to the cornea, even those that eventually heal, can result in eye damage due to inflammation within the cornea. Also, eye drops with certain preservatives to maintain sterility can cause inflammation that can damage the eye.

It is estimated there are 200,000 vitrectomies (removal of the gel-like fluid inside the middle of the eye) in the U.S. each year and another 360,000 in the rest of the world. Many of these surgeries are performed in diabetic patients who often have difficulty healing. Due to an aging population, epidemic increases in diabetes and diabetic retinopathy, the incidence of vitrectomy surgery is growing at 5.5% per year and more retinal specialists are being trained to perform vitrectomies.

In animal studies, Tß4 has been shown to prevent apoptosis, reduce inflammation and accelerate healing of the cornea, thus offering several potential market opportunities. RegeneRx is pursuing clinical trials to evaluate the ability of Tß4 to reduce inflammation and damage associated with eye surgery.