Burns represent 5%-20% of all combat-related injuries, 20% of which are considered severe or involve more than 20% of total body surface area, resulting in significant cost of care as well as long-term complications including functional impairment and disfigurement (data from US Army studies). According to the American Burn Association, each year in the United States, 40,000 cases require hospitalization with an estimated annual expenditure of >$2 billion direct costs of care and much greater indirect costs secondary to unemployment (http://www.ameriburn.org/resources_factsheet.php. American Burn Association Incidence Fact Sheet 2016).

Burns cause pain for at least three days and this correlates with continuing damage and death to tissue surrounding the burn for as long as three days post-burn. There is no treatment for this progressive tissue damage and death and its accompanying pain. NeoMatrix Therapeutics, Inc. (NMT) in Stony Brook, NY, has developed a drug that limits the progressive tissue damage around a burn and speeds healing.

The Department of Defense, through the Congressionally Directed Medical Research Programs, has invited NMT to submit a proposal to support a Phase 1 clinical trial, for our drug product, titled "A Phase 1 Randomized, Placebo-Controlled, Single Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cP12 in Healthy Adults." The clinical trial will test the drug "cP12 for injection" for the first time in humans. Preclinical results demonstrate that the drug given at the highest dose planned, to be given in the Phase 1 clinical trial, should not have any side effects other than possible transient, redness, and itching around the site of intravenous injection. Such a Phase 1 clinical trial in normal healthy volunteers is required by the FDA prior to use in patients with burns.

If the Phase 1 clinical trial demonstrates the drug is safe in healthy volunteers, the next clinical study will be performed in patients with small burns. If the drug is safe and appears effective in patients with small burns, the drug will be tested in two additional, larger studies in patients with more extensive burns that have been admitted to burn centers around the country. The Phase 1 clinical trial, once approved and funded, will take approximately six months to complete. The follow-up studies will take several years to complete.

If cP12 is successful in limiting burn injury progression, it will provide transformative therapy and a new standard of care for victims of serious burn injury. With this therapy wounded warriors would be less likely to suffer immediate or long-term consequences of burn injuries and be more likely to return to duty, fully able to serve. More specifically, wounded warriors, veterans, and civilians with substantial burn injuries would have decreased suffering, decreased length of hospitalization, decreased need for surgery, and decreased hospital and rehabilitation costs. In the long-term, patients should have less functional impairment and less disfigurement from scarring. Furthermore, the time, effort, and stress of family members and caregivers would be greatly decreased due to these burn victims having less pain, scarring, functional impairment, and, of course, their quicker recuperation and return to home.