A Medical Device Daily

Cleveland BioLabs (Cleveland) said it has entered contract negotiations with the Defense Threat Reduction Agency (DTRA) of the Department of Defense (DoD). Cleveland BioLabs submitted a proposal for a collaborative project with the Armed Forces Radiobiology Research Institute (Bethesda, Maryland) to complete development of radiation protectors in response to the Radiological Countermeasures research area. The company said it has been identified as an “apparent successful offeror” by the DTRA and negotiations are in progress, according to the company.

“Our participation in this program would be a significant milestone for the company,” said Michael Fonstein, PhD, president/CEO. “A contract resulting from this program would support further development of our line of radioprotectant drugs, as well as establish a path for procurement with the DoD.”

Protectan CBLB502, the company’s lead radioprotectant molecule, has demonstrated its efficacy in a recent study when it rescued more than 70% of lethally irradiated primates and substantially delayed death for those that died. CBLB502 is undergoing an accelerated development program under the FDA two-animal rule, which requires the company to show efficacy in two animal species (including primates) and only safety in humans.

Cleveland BioLabs says it is “leveraging” its discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses.

In other grant news:

• The Minneapolis Heart Institute Foundation atAbbott Northwestern Hospital (Minneapolis) has partnered with three Minnesota healthcare providers to create the Minnesota Cardiovascular Cell Therapy Clinical Research Network (MnCTN), which recently received a $1.5 million grant from the National Institute of Health to research stem cell treatments for heart disease.

In addition to the Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, MnCTN comprises the University of Minnesota Division of Cardiology, the Center for Cardiovascular Repair , and the Molecular and Cellular Therapeutics lab; Hennepin County Medical Center ; and the Veterans Administration Medical Center .

MnCTN is one of five organizations across the country selected to receive the grant and participate in the MnCTNetwork, created to facilitate clinical trials to examine the success of new cell therapies for the treatment of heart conditions including heart attacks and heart failure.

Specific areas of research the MnCTN has proposed examining include using bone marrow-derived stem cells to initiate cardiac repair following a heart attack and using patients’ own stem cells to treat heart failure.

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