A novel skin substitute called the Biodegradable Temporizing Matrix, will take the next development steps under a three-year, $8.2 million contract with PolyNovo Limited of Port Melbourne, Australia awarded by Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
The development is part of an effort by ASPR’s Biomedical Advanced Research and Development Authority (BARDA) to develop new medical products to protect health and safety during chemical, radiological or nuclear emergencies, particularly those involving explosions. Some of these products also may find more common uses, such as among victims of fires.
Meanwhile, BARDA also is involved in enhancing radiological and nuclear attack preparedness with new products, Homeland Security Today reported this week. Additionally, HHS is advancing development of novel antivirals to treat influenza, and a separate partnership to develop new antibiotic.
Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.
The Department of Health and Human Services (HHS) is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recoverfrom adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
The new development for "treatment of severe burns requires surgical intervention to fully repair damaged skin. Patients with large burns may not have enough healthy skin available to serve as donor skin grafts to repair all of their severely burned areas,” HHS said in an announcement. “To close the wounds and help the underlying tissue heal in such cases, doctors can apply a wound and burn dressing known as a temporizing matrix made of material that is compatible with the body and breaks down in the body over time.”
HHS said, “If development is successful, the Biodegradable Temporizing Matrix also will prevent wound contraction in which the wounded tissue tightens and becomes less flexible. Wound contraction can result in a loss of function of that part of the body and in severe cosmetic problems for the patient.”
The matrix material is being designed to help prepare the wounded area for skin grafts at a later time while enabling immediate life-saving treatment for the patient. As the patient’s own tissue heals, the tissue is expected to integrate into the inner layer of material as the matrix slowly dissolves. Doctors then could remove the outer layer of the matrix and graft over the area when donor skin becomes available.
This step-by-step approach to treating patients with large burns is especially important for mass casualty incidents with an overwhelming number of patients and scarce critical medical resources. Currently, the Food and Drug Administration has approved only one product that can be used for coverage of severe burns in preparation for wound closure with the patient’s own skin grafts.
If successful, the Biodegradable Temporizing Matrix may be easier to use, have an extended shelf-life, and be less expensive than the approved product, important attributes for emergency preparedness.
Under the agreement with BARDA, PolyNovo will perform an early clinical study, known as a feasibility clinical trial. The company also will perform additional non-clinical studies, as well as manufacture material for their studies.
The contract can be extended for up to a total of five years and up to $26.3 million. If extended, the contract would support additional non-clinical and pivotal clinical studies as needed to file for approval by the FDA.
Recognizing that doctors will need a variety of effective ways to diagnose and treat the wide range of illnesses and injuries resulting from a radiological or nuclear incident, BARDA maintains a robust advanced development portfolio of products to treat injury from thermal burns and acute radiation exposure, including blood, gastrointestinal, lung, and skin injuries. These development projects include eight products to treat skin injuries.
BARDA also supports the development of medicines to treat radiation-combined injury in which the effects of radiation are combined with burns, blast injury, or other trauma. Theseefforts complement the existing research and development portfolios of government partner agencies, such as the Department of Defense.
Many of the products that BARDA is developing may find uses outside of emergency medicine, especially in the case of blood and burn products. The development of such medical products improves the nation’s preparedness by increasing the number of products available for emergencies. Because the products also can be used in day-to-day medical situations the market for these emergency products can be sustained without the need for government stockpiling.
BARDA is seeking additional proposals for products that could be used to treat illnesses and injuries caused by disasters. Visit www.medicalcountermeasures.gov or the Federal Business Opportunities [BAA-12-100-SOL-00011] for the latest opportunities.