Cleveland Biolabs' CBLB502 Granted Fast Track Status From FDA

Cleveland Biolabs Inc. (CBLI)'s CBLB502 for Reducing the Risk of Death Following Total Body Irradiation During or After a Radiation Disaster Granted Fast Track Status From FDA

BUFFALO, NY--(Marketwire - 07/22/10) - Cleveland BioLabs, Inc. today announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).

The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review, which may result in an abbreviated review time of six months.

"We are extremely pleased that the lead indication for CBLB502 has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program's review process," said Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs.

About CBLB502 CBLB502 is a derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

CBLB502 is being developed by Cleveland BioLabs under the FDA's Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident. 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 human subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. Dosing of 100 subjects in a second human safety study for CBLB502 was completed in May. Analysis of safety and biomarker data from this study is ongoing. There is currently no FDA approved medical countermeasure to reduce the risk of death following total body irradiation.

About Cleveland BioLabs, Inc. 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.

Suggested Articles

MicuRx nabbed $7.78 million from a nonprofit focused on antimicrobial resistance to push its third antimicrobial program into human trials.

The FDA has handed Scholar Rock a rare pediatric disease designation voucher, which can allow the biotech a speedy review of its SMA med.

The FDA has placed a phase 1/2 trial of Passage Bio’s GM1 gene therapy on clinical hold pending further assessment of the risk of its delivery device.