Cleveland BioLabs shares rocket on progress of anti-radiation drug candidate

Shares in Cleveland BioLabs Inc (NASDAQ:CBLI) shot up over 53% in New York Monday as the FDA gave it the go-ahead for a  biocomparability study on its candidate entolimod in non human primates.

The biotech’s flagship product is being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.

The US FDA has now completed a review of a side-by-side analytical comparison of two formulations of entolimod and agrees with Cleveland BioLabs that the data shows the in vitro analytical comparability of the formulations.

The aim of this study is to compare the historical drug formulation used in prior nonclinical and clinical studies versus the to-be-marketed drug formulation of entolimod submitted for approval under CBLI’s application for pre-Emergency Use Authorization (pre-EUA).

Yakov Kogan, the group’s chief executive officer, said: “Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier.”

The planned study is funded in part by the Department of Defense (DoD) Joint Warfighter Medical Research Program (JWMRP).

This contract is valued at up to $9.2 million and supports further development of entolimod as a medical radiation countermeasure.

Cleveland shares rose 53.21% to $2.39.

Story by ProactiveInvestors