Orlando, FL 6/4/12 (StreetBeat) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced 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.
Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance, stated, "We are very pleased with the compelling survival data reported in this study. In addition to demonstrating CBLB502's effect on survival, we believe this study supports our methodology for dose conversion between animals and humans. We plan on using the findings from this trial as a basis for finalizing our remaining development steps with the FDA and, ultimately, submitting our Biologic License Application."
Yakov Kogan, Ph.D., MBA, interim Chief Executive Officer, commented: "I congratulate our team on the rigorous execution of this study. To our knowledge, this trial is the first ever GLP/GCP compliant, randomized, blinded study done with any radiation countermeasure. CBLB502 continues to exceed our expectations and we are as committed as ever to moving this program forward."
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