Among the members of Martin Hauer-Jensen's research team are, front row, left to right: Marjan Boerma, Ph.D., Daohong Zhou, M.D., Junying Zheng, Ph.D., Junru Wang, M.D., Ph.D., Martin Hauer-Jensen, M.D., Ph.D., Howard Hendrickson, Ph.D., Wenze Wang, M.D., Ph.D., Rupak Pathak, Ph.D., Alan Tackett, Ph.D. Back row, left to right: Lin Song, Wei Feng, M.D., Liya Liu, Sarita Garg, Ph.D., Maaike Berbee, Yi Luo, M.D., Ph.D., Jianhui Chang, Lijian Shao, M.D., Ph.D.
Martin Hauer-Jensen, M.D., Ph.D.
Oct. 8, 2013 | The Biomedical Advanced Research and Development Authority (BARDA) has exercised two contract options worth approximately $8.7 million with the University of Arkansas for Medical Sciences (UAMS) to proceed with advanced development of a promising treatment for use in radiological or nuclear emergency situations.
The first option by BARDA, which is part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is for $7.5 million over two years. A second one-year option for $1.24 million is for research to be done as part of an interagency agreement between BARDA and the U.S. Department of Defense (DOD).
Including the base BARDA contract for $4.5 million entered into in 2011, the total value awarded is more than $13 million.
Under the contract, UAMS’ Martin Hauer-Jensen, M.D., Ph.D., an internationally renowned radiation researcher, will lead the evaluation of the drug, pasireotide, formerly known as SOM230, to treat gastrointestinal injuries after radiological or nuclear accidents or terrorist attacks. Hauer-Jensen will be assisted by an 18-person team of UAMS researchers.
The intestine and bone marrow are most susceptible to radiation because of their rapidly proliferating cells. Treatments exist for irradiated bone marrow but not for the intestine.
Radiation damage to the intestine often determines whether a person lives or dies after exposure, Hauer-Jensen said.
The potentially life-saving pasireotide inhibits the secretions from the pancreas, giving the intestine a chance to heal after radiation exposure. Assuming the drug also receives FDA approval to treat gastrointestinal injuries from radiation exposure, it would be a breakthrough for emergency preparedness as one of a very small number of drugs that protects people after they’ve already been exposed to radiation.
Hauer-Jensen said that it is his hope that the drug will someday be available to address public health emergencies and to benefit cancer patients receiving certain radiation therapies.
“I am very excited about this award, and I am optimistic that in a few years we will have a safe, effective treatment with the potential to saves lives,” said Hauer-Jensen, associate dean for research and director of the Division of Radiation Health in the UAMS College of Pharmacy.
The research contract is the largest in the UAMS College of Pharmacy’s 60-year history, said Stephanie Gardner, Ed.D., Pharm.D., dean of the College of Pharmacy.
“This award is a great achievement for Dr. Hauer-Jansen and his team,” Gardner said. “It is also a great achievement for our college and highlights the fact that we not only have a wonderful academic program, but that we are also excelling in the research arena.”
Novartis developed the pasireotide to treat hormone disorders known as Cushing’s disease and acromegaly. The U.S. Food and Drug Administration (FDA) and the European Union recently approved the drug for the treatment of Cushing’s disease.
In the first phase of the research begun in 2011, Hauer-Jensen and his team generated data Novartis needed to initiate discussions with the Food and Drug Administration about using pasireotide for radiological emergencies. During the next two years of the contract, the team will perform a range of studies to continue the development process.
“At the end of this contract period, we’ll be ready to do the pivotal studies as well as drug interaction studies involving other countermeasures used in radiological emergencies, and then hopefully get pasireotide approved by FDA for gastrointestinal injury in acute radiation syndrome,” Hauer-Jensen said.