The Biomedical Advanced Research and Development Authority has issued five separate contracts, totaling $56.6 million, to biomedical firms to support development of drugs to treat injuries associated with acute exposure to radiation.

BARDA is an agency within the Office of the Assistant Secretary for Preparedness and Response in the department of Health and Human Services. As such, it is charged with advancing research and development of countermeasures to bioterror threats and the effects of nuclear fallout, such as acute radiation exposure, that can lead to injuries to multiple organs, hemorrhaging, infection, and suppression of the immune system's ability to fight organisms that cause infection.

The contracts bring to $89.4 million the total awarded this year to find new ways to treat injuries caused by exposure to high levels of radiation. It is a boon to the companies, which stand to benefit from a dual purpose use for their investigational compounds. They are developing drugs to treat bone marrow, gastrointestinal, lung, and skin injury caused by radiation, injuries for which there are currently no treatments available. BARDA expects to expand the list to include treatments for thermal burns that might be caused by a nuclear detonation.

“These contracts support development of products that have the potential to address urgent public health requirements for radiation medical countermeasures while also meeting other unmet medical needs,” says BARDA Director Robin Robinson. “For example, they may find day-to-day use in treating the side effects of cancer radiation treatment and chemotherapy. These advanced development contracts demonstrate what can be achieved by repurposing drugs with commercial potential to meet public health emergency requirements, and we would like to encourage other pharmaceutical companies and their collaborators to follow this approach.”

California-based Neumedicines and Cellerant Therapeutics, Tennessee-based RxBio, New York based Araim Pharmaceuticals, and Florida-based Nanotherapeutics are the five biotechs that just received contracts to help support the development of their products.

Neumedicines, focused on novel protein therapies to treat hematopoietic deficiencies due to the cancer side effects of radiation therapy and chemotherapy, will receive $17 million over 18 months to speed development HemaMax, its recombinant human interleukin-12. The money will be used to evaluate its safety and efficacy and further develop manufacturing processes. This contract follows a 2008 award that was used to establish proof-of-concept and show that HemaMax mitigates bone marrow damage caused by damaging radiation. BARDA has the option of extending the contract an additional three and a half years, potentially bringing its total value to $273 million.

RxBio will use the funding from its two-year, $15 million contract to study the efficacy of its drug Rx100, which may protect against radiation-induced gastrointestinal injury by interrupting programmed cell death. Preliminary data suggests that Rx100 can protect or mitigate injury and improve survival if administered up to 72 hours after deadly whole-body radiation exposure. The contract also supports development of manufacturing processes for the drug.

Araim Pharmaceuticals will receive $3.1 million over two years to conduct studies of ARA 290 to evaluate whether the drug improves overall survival when it is administered 24 hours or longer after exposure to high doses of ionizing radiation. With anti-inflammatory properties and tissue-protective properties, the drug has shown promise in treating stroke, heart disease, and kidney failure. The studies under this contract are the next step in the drug development process and are needed before proceeding to clinical trials and pivotal efficacy studies.

Nanotherapeutics will use an 18-month $4.8 million contract to support development of an oral drug to treat internal contamination from radiation such as from a dirty bomb. As a chelating agent, DTPA can bind radioactive molecules to help the body remove them. It can be used to treat people who have inhaled or swallowed radioactive particles, or who have radioactive particles that entered the body through wounds. Currently, it must be administered intravenously or by nebulizer, limiting its usefulness in an emergency.

Nanotherapeutics will conduct studies to develop an improved formulation of DTPA and improve manufacturing processes for it. BARDA may extend the contract for a total of up to five years and up to $31.1 million.

Finally, BARDA extended a 2010 contract with Cellerant Therapeutics for a second year and an additional $16.7 million. Cellerant will continue studies and manufacturing activities to further develop its cell therapy to treat neutropenia, an abnormally low number of white blood cells caused by exposure to high levels of ionizing radiation. Cellerant's drug, called CLT-008, uses myeloid progenitor cells, which can grow into any kind of blood cell the body needs. It is being developed to support and add to the patient's own progenitor cells, providing protection for patients against life-threatening infections and hemorrhaging while their own bone marrow is recovering.