Federal regulators have given the green light to Cleveland BioLabs to move ahead with its efforts to win the approvals needed so that its anti-radiation sickness drug could be stockpiled for emergency use.
Company executives and investors believe that authorization from the U.S. Food and Drug Administration is the fastest route for turning Entolimod – the most advanced of Cleveland BioLabs’ drug candidates – into a revenue producer.
Cleveland BioLabs executives had met with FDA officials in July, but only now received clearance to proceed with its emergency use application.
“The outcome of our FDA meeting is very positive,” said Yakov Kogan, Cleveland BioLabs’ chief executive officer.
Completing the application is expected to take until sometime during the first half of next year. The FDA then will review the application, but it is under no formal timetable to make a ruling on it once it has been received, Kogan said.
Cleveland BioLabs executives believe that studies conducted so far have shown great promise for Entolimod as an anti-radiation sickness drug that company officials believe could be stockpiled by governments worldwide to protect citizens and soldiers in the event of a nuclear accident or a terrorist attack.
The tests that the company has conducted so far have shown encouraging results that a single dose of Entolimod, administered up to 25 hours after exposure, can greatly increase survival rates following a potentially lethal exposure to radiation. But further studies must be done before Cleveland BioLabs can start selling the drug, and those additional tests will take a considerable amount of both time and money.
Cleveland BioLabs executives estimate that it will cost about $1.25 million – and the time of five full-time staff members – to compile its emergency application and compile the additional information and data that the FDA indicated it wants to see. That additional information will make completing the application almost twice as expensive as Cleveland BioLabs executives initially thought.
“This is not a light undertaking,” said Ann Hards, Cleveland BioLabs’ executive vice president of regulatory affairs.
Cleveland BioLabs currently has enough cash to fund its operations into the first quarter of next year. Kogan said the company is planning to hold discussions with various federal agencies about providing funding for the emergency application and the additional studies needed for the drug to be considered for non-emergency use.
In the meantime, the company will help fund the emergency application by using money that had been budgeted for studies related to Entolimod’s potential use as a treatment for bladder cancer, said Neil Lyons, Cleveland Bio-Labs’ chief financial officer.