Biomedical Advanced Research and Development Authority (BARDA) Exercises Options on Cleveland BioLabs $15.6 Million Contract to Develop Radiation Countermeasure CBLB502
– By April Murelio –
Cleveland BioLabs, Inc. has announced that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) exercised the second and third milestone-based options on the Company’s existing contract under the Broad Agency Announcement titled, “Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation,” for selected tasks in the advanced development of Protectan CBLB502. The value of the contract, originally awarded in September 2008, is $15.6 million over a three-year period, including an increase in the first milestone-based option which was exercised in September 2009.
Option two includes $1.47 million to support additional manufacturing and release of a new current good manufacturing practice (cGMP) lot of CBLB502, as well as additional animal studies. Option three includes $0.46 million to support additional good laboratory practice (GLP) efficacy studies in non-human primates, where CBLB502 will be administered on the background of supportive care. All of these activities are necessary for completion of a Biologic License Application (BLA) for the U.S. Food and Drug Administration (FDA).
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, “BARDA’s decision to exercise these milestone-based funding options under our development contract is further indication of the progress we have made in advancing CBLB502 towards submission for FDA licensure. We look forward to continuing our collaborative efforts.”
CBLB502 is a derivative of a microbial protein, which has demonstrated the capacity to reduce injury from acute stresses, such as radiation and chemotherapy, in animal models. CBLB502 mobilizes several tissue protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.
CBLB502 is being developed under FDA’s Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS). This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human volunteers.
Evidence of CBLB502's mechanism of action and activity in animal models was published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp. 226-230). Data from 50 subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker data was consistent with previously demonstrated activity in animal models of ARS. There is currently no FDA approved medical countermeasure to treat ARS.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.