HOLLIS-EDEN ENDS DEVELOPMENT OF ARS DRUG NEUMUNE

Hollis-Eden Pharmaceuticals announced it has decided to end development of its preclinical drug candidate for treating acute radiation syndrome (ARS), Neumune, after meeting with HHS to discuss the agency's decision to exclude Neumune from a solicitation for potential ARS treatments and to cancel the solicitation in its entirety.

HHS told the company that, while the compound is promising and met the mandatory requirements of the solicitation, the amount of data available on Neumune was not sufficient to justify an advance purchase contract under Project BioShield. Based on the comments made, Hollis-Eden believes the concerns of the agency could only be satisfied with pivotal safety and efficacy trials, which the company said it is not prepared to fund in the absence of an advance purchase contract. The agency also said it anticipates issuing a new request for proposal for products to treat ARS in the future.

"We believe Neumune is clearly the compound farthest along in development for the acute effects of radiation injury," Richard Hollis, chairman and CEO of the company, said. But, he said, "In light of these actions by HHS, we have made the strategic decision to curtail further development of Neumune."