On the heels of the European Medicines Agency providing a positive opinion on entolimod, shares of the drug maker, Cleveland BioLabs Inc. (NASDAQ:CBLI) have slingshot ahead in Monday trading. The EMA accepted the company's pediatric investigation plan, a move that clears the path for CBLI to submit a Marketing Authorization Application for entolimod as a medical radiation countermeasure for the prevention of death from acute radiation syndrome.
Entolimod is a recombinant protein that acts as an agonist of the innate immunity receptor TLR5. Acute radiation syndrome (ARS) can be a lethal side effect of radiation exposure due to severe damage to gastrointestinal, hematopoietic and other vital body tissues. Research supports the ability of entolimod to trigger a spectrum of protective immune responses to combat ARS.
The EMA requires a pediatric investigation plan, or PIP for short, from pharmaceutical companies to explain their strategy for investigating a new therapy in young children.
Shares of CBLI rose at a blistering pace on the news, even threatening to top the 52-week high of $3.30 set last June. After closing Thursday at $1.56, shares have soared as high as $3.20 in Monday's session. CBLI shares have since pulled back in Tuesdays session as some investors take profits. CBLI shares are currently down $1.00 or 20.83 percent at $3.80.
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