|CBLI officials in touch with appropriate U.S. agencies as Japan's nuclear reactors remain unstable|
|Tuesday, 15 March 2011 11:02|
Workers are scrambling to cool down fuel rods and prevent a full meltdown in three reactors at the earthquake-hit Fukushima Daiichi plant. Japanese Prime Minister Naoto Kan warned Tuesday that the risk of further releases of radioactive material from the plant remains "very high."
“It really is difficult to interpret from the news what really is happening, government officials claim the situation is under control,” said Cleveland Biolabs’ CEO, Michael Fonstein in an telephone interview. “The situation could deteriorate and someone should provide doses to protect the workers, so that they can be protected in case of exposure, regardless of deterioration. We believe our drug can help.”
“You know that there are certain U.S. agencies which are responsible for our own counter-measures and these same agencies are also responsible for dealing with international issues in this area, so we have been following clear protocols to make them aware that we have doses of CBLB502 which could be made available for potential emergency use.”
While there are no other drug-candidates which work as well or have been proven to be as safe thus far anywhere, the issue with CBLB502 is that the drug is currently fast-tracked but not yet approved by the FDA. That means that while it has undergone numerous safety and efficacy trials, it is not yet licensed under FDA final approval for sale to the market. If the U.S. or Japanese governments decided to use the drug to protect personnel or clean-up crews, it would have to be made available under certain emergency use considerations.
“Obviously, this has to be tied into some type of approval- probably under emergency use authorization- if they decide to use it,” said Fonstein. “Whatever the Japanese feel they need, they will have to decide for themselves, but we are willing to make a certain number of doses available to them.”
Prior to today, officials at the company were the ones reaching out to let people know they had doses of this drug, but sources close to the situation tell BioMedReports that there appears to be more back and forth communications activity as conditions with the reactors appear to be worsening.
“As far as getting into details as to which agencies we have been in contact with, I can only use the term ‘appropriate U.S. agencies,’” explains Fonstein. “At this point I would not be comfortable to be more specific. But we have been speaking through the approriate channels and have actually made them aware that we do have doses available and on-hand.”
When asked how many doses the company had ready, company spokesperson Rachel Levine would only say that “these are doses coming out of the stock that had been set aside for our human trials. It’s a batch that the FDA has approved for that purpose. God forbid, if the situation were to become much worse or much dire, those are the doses that we have made people aware of exist.”
The company had no update, but said they continue to expect news about a pending $50+ million dollar grant from due from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS). These monies are to be allocated for continued development of CBLB502 and will eventually lead to an RFP for the U.S. National Stockpile.
Disclosure: Long CBLI