Cleveland Biolabs (CBLI) Shares Rally as Efficacy Study for CBLB502 Showed Strong Survival Results
Tweet
Share
E-mailGet Alerts CBLI Hot Sheet
Join SI Premium – FREE
Shares of Cleveland Biolabs (Nasdaq: CBLI) have surged sharply Monday morning following earlier news of strong survival results for its randomized, blinded, placebo-controlled efficacy study of CBLB502 in 179 non-human primates (NHPs) conducted under Good Laboratory Practice (GLP) with elements of Good Clinical Practice (GCP), as required by the U.S. Food and Drug Administration's (FDA) Animal Rule. The study demonstrated with a high degree of statistical significance the dose-response relationship between the administration of CBLB502 and the survival of lethally irradiated animals, the study's primary endpoint.
Animals in the study received a 70% lethal dose of total body irradiation (TBI) followed by a single injection of a range of doses of CBLB502 or a placebo, in each case, 25 hours after irradiation. In addition to determination of 60-day survival, the study measured multiple pharmacodynamic parameters which the Company believes are essential for animal-to-human dose conversion.
A minimal efficacious dose of CBLB502 was determined and doses above the minimal efficacious dose formed a plateau at approximately 75% survival, compared to 27.5% survival in the placebo treated group. These results demonstrated with a high degree of statistical significance (p < 0.0001 for the trend up to the 40 ug/kg dose and p = 0.0021 for the trend up to the 10 ug/kg dose) that a single administration of CBLB502 given 25 hours after TBI led to a nearly three-fold increase in overall survival in the subject animals.
Cleveland Biolabs shares last traded at $2.07, up more than 60 percent from Friday's closing price.
Animals in the study received a 70% lethal dose of total body irradiation (TBI) followed by a single injection of a range of doses of CBLB502 or a placebo, in each case, 25 hours after irradiation. In addition to determination of 60-day survival, the study measured multiple pharmacodynamic parameters which the Company believes are essential for animal-to-human dose conversion.
A minimal efficacious dose of CBLB502 was determined and doses above the minimal efficacious dose formed a plateau at approximately 75% survival, compared to 27.5% survival in the placebo treated group. These results demonstrated with a high degree of statistical significance (p < 0.0001 for the trend up to the 40 ug/kg dose and p = 0.0021 for the trend up to the 10 ug/kg dose) that a single administration of CBLB502 given 25 hours after TBI led to a nearly three-fold increase in overall survival in the subject animals.
Cleveland Biolabs shares last traded at $2.07, up more than 60 percent from Friday's closing price.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Super Micro Computer (SMCI) Falls 6%
- Mondi Says It Does Not Intend To Make An Offer For DS Smith
- Recent IPO Top Wealth Group (TWG) trading 90% higher
Create E-mail Alert Related Categories
Corporate News, FDA, Momentum MoversSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
