BARDA's $60M plan to protect against radiation poisoning

September 30, 2011
by Brendon Nafziger, DOTmed News Associate Editor
Federal officials announced they were funding the development of five drugs designed to protect people from the horrors of radiation poisoning. The government's also financing studies to develop an improved version of another drug to treat people exposed to radioactive particles that could be released during a so-called dirty bomb attack.

Biomedical Advanced Research and Development Authority, or BARDA, a division of the Department of Health and Human Services, announced the roughly $60 million in funding in a series of releases Wednesday and Thursday.

About $56.3 million will go toward five contracts for a variety of drug companies and scientists working on countermeasures for acute radiation syndrome, or radiation sickness. When exposed to high doses of ionizing radiation -- such as from a nuclear bomb blast -- fast-reproducing cells in the gut, bone marrow, and lungs can be destroyed, which can in turn lead to internal bleeding, a depressed immune system and death over the following days or even weeks.

Winners of contracts include Neumedicines Inc., which got a $17 million award to study recombinant human interleukin-12 (rhuIL-12). Also called HemaMax, a 2008 BARDA-funded study showed it might be able to protect bone marrow from radiation.

Johnson City, Tenn.-based RxBio Inc. nabbed a two-year, $15 million contract to study Rx100, a small molecule-drug which might be able to prevent cells in the gut from dying if administered up to three days after radiation exposure. As with many of these radioprotectants under investigation, the company also said the proprietary substance -- which it says can be stored at room temperature and has a long shelf-life -- could help reduce GI chemotherapy side effects.

University of Arkansas for Medical Sciences also got a contract to research a drug, SOM230 or pasireotide, to protect the gut from radiation. The two-year, $4.5 million contract covers research on the substance, an analog of the hormone somatostatin, which was developed by pharama giant Novartis to treat various endrocrine tumors and Cushing's disease, a condition caused by the body's over-production of cortisol. The university researchers will try to provide results that Novartis can use to submit a Food and Drug Administration application for the drug, which apparently works by preventing pancreatic secretions that inflame the intestines.

Under a two-year, $3.1 million contract, Araim Pharmaceuticals, an Ossining, N.Y.-based biotech startup, will see if its drug, ARA 290, could help save lives up to 24 hours after radiation exposure. In tests on animals, the substance, which mimics a hormone found in the body and prevents cell death and inflammation, was found to protect against lethal doses of radiation, as well as to speed up wound healing, reduce brain, kidney and heart injuries from trauma or disease, and even improve learning.

On top of these grants, BARDA is extending its 2010 contract with Cellerant Therapeutics for another year. With the new $16.7 million award, the San Carlos, Calif.-based startup will continue to study CLT-008, a drug derived from adult stem cells. According to early studies, it could help the body re-grow white or red blood cells for protection from infection and internal bleeding while recovering from radiation exposure. BARDA first gave Cellerant about $11 million in 2008 in its initial contract. Last year, the agency signed a five-year deal with Cellerant worth up to $153 million, depending on performance.

Oral chelating agent

But not all the research is for new drugs. BARDA has also given Nanotherapeutics Inc. of Alachua, Fla. a year-and-a-half-long, $4.8 million contract for improving the manufacturing process for diethylenetriaminepentaacetate (DTPA). A chelating agent, DTPA binds to certain radioactive particles, such as americium, curium or plutonium, and helps remove them from the body. These are the types of particles that could be inhaled, or enter through wounds, after the explosion of a radiological or dirty bomb.

DTPA is approved by the Food and Drug Administration, but in its current forms it generally has to be used intravenously. But the new formula, NanoDTPA, could be taken by mouth, making it potentially more useful during an emergency.

"This is the first contract BARDA has awarded for the advanced development of an oral chelating agent to treat internal radiation contamination, and represents a milestone for our program," BARDA Director Robin Robinson said in a statement.

Previously, BARDA has developed and bought two other chelating agents, Ca-DTPA and Zn-DTPA. The agency said it's also supporting the development of a liquid version of Prussian blue, a non-chelating drug for treating contamination with cesium-137, a radioactive isotope that could be shed into the environment during a nuclear attack or power plant accident.

Nanotherapeutics' contract can be extended for up to five years, for a total worth of up to $31.1 million, BARDA said.