Principal Investigator: Richard A. Clark, MD
Organization: NeoMatrix Therapeutics
Rationale, objective, and aims for the proposed project:
In this study, NeoMatrix Therapeutics (NMT) plans to complete the first clinical trial for intravenous (IV) cP12 drug product in burn patients. Since burn injuries tend to worsen over time, particularly in size and severity, it is critical to find ways to slow down the process. This process is known as burn injury progression. When tested in animals, treatment with our drug cP12 healed over twice as many burn wounds by 14 days after the burn compared to no drug treatment. When tested in healthy normal adult volunteers, the IV cP12 infusion caused no severe side effects when given at doses almost three times higher than burn patients will be given. Therefore, we believe that the therapy will also be safe when given to burn victims. Furthermore, we hope to see burn wounds heal faster in patients given the drug treatment than burns in patients not given the treatment.
What is the ultimate applicability and impact of the research?
-What types of patients will it helped, and how will it help them?
Historically, burn injuries account for 5-20% of all injuries inflicted on American military personnel. Of these 20% are considered severe or involve more than 20% of total body surface area. In addition, substantial burns occur in about 500,000 US civilians every year. Of these injured civilian burn victims about 40,000 are sufficiently severe and/or extensive to warrant hospitalization. Furthermore 4,000 US civilian deaths, related to burns, occur yearly. The direct cost of burn care in the US is about $2 billion/year.
We believe that cP12 delivered IV to wounded warriors, veterans, or civilian patients will limit burn injury progression, speed healing, and reduce scarring. If successful, IV cP12 therapy would be transformative for burn care of wounded warriors and civilians by reducing or eliminating immediate and/or long-term consequences of localized, severe burns. These burn victims would be more likely to have shorter hospital stays, return to duty or work more quickly, and resume independent lives with their families.
Describe the ultimate applicability of the research.
-What types of patients will it help, and how will it help them?
Particularly relevant burns in wounded warriors are those on central face, ears, hands and feet of combat soldiers because they wear body armor that protects the trunk but not the face and distal extremities. However, the clinical application extends to any skin burn wound regardless of wound source or size. In all cases, skin pain and infection should decrease, healing increase, and ultimate scarring decrease.
We believe that this cP12 IV therapy will slow burn progression, speed healing, and ultimately reduce scarring and disfigurement.