BioLabs seeks $50M from Feds to Advance Drug Development

October 19, 2012 Updated Oct 19, 2012 at 8:31 AM EDT

By WKBW News
By Business First by Tracey Drury

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October 19, 2012 Updated Oct 19, 2012 at 8:31 AM EDT

BUFFALO, NY (WKBW) - Cleveland BioLabs Inc. is asking federal agencies for $50 million to help fund the final development of its radiation countermeasure drug.

The proposal to the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (BARDA) seeks funding to complete the development steps to license Entolimod as a medical radiation counter-measure.

It follows ongoing discussions this summer with the U.S. Food and Drug Administration to finalize what steps CBLI should take to move the project forward, said Neil Lyons, chief financial officer for the Buffalo company (NASDAQ: CBLI).

"We have been in discussions with BARDA for a little over a year now, and also with the FDA, in confirming what needs to be done to move our project forward," he said. "We made great progress with them. Now we've come to a point where we have an agreement on the specificity of the details procedures and studies."

Six months ago, CBLI's stock plunged 35 percent to $1.54 per share after BARDA turned down the company's proposal for continued development funding of its compound, previously known as CBLB502 before it was renamed Entolimod. Company officials said in a statement they would continue to develop the compound to treat acute radiation syndrome caused by exposure to radiation from a nuclear or radiological weapon or from nuclear accidents.

Thursday afternoon, the company's stock was back up, trading at $2.50 per share.

The new proposal to BARDA addresses pivotal animal efficacy and clinical programs as well as animal-to-human dose conversion. Though the ongoing discussions with the agency and FDA do not guarantee funding, Lyons was hopeful the company will meet the government's requirements.

"There are no radiation countermeasures in the national stockpiles. The government wants one that is approved, so we have gone to the FDA and confirmed what needs to be done to get this drug approved," he said. "From a competitive standpoint, there are other companies trying to develop a countermeasure, but none is anywhere near us."

BARDA's decision on the contract could take as long as six months.

The company has previously received federal funding for the drug totaling more than $50 million from BARDA, the Department of Defense and the National Institute of Allergy and Infectious Diseases. Earlier this month, development efforts for the drug received a boost in funding totaling $770,442 from the U.S. Department of Defense through its Defense Threat Reduction Agency contract. The original contract award from 2011 was for $1.58 million.

The proposal for $50 million more would support development work here in Buffalo, including work contracted out to other agencies, as well as a human safety study at up to five sites around the country.

Cleveland BioLabs is a clinical stage biotechnology company developing drugs for both oncology applications and the mitigation of radiation injury.

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