BUFFALO, NY -- (Marketwire) -- 01/25/11 -- Cleveland BioLabs, Inc. (
Michelle Ross, DVM, M.S, Ph.D., Senior Vice President of Public Health and Government Services for Cleveland BioLabs, commented, "We are very excited about expanding our working relationship with DTRA, and the DoD as a whole. DTRA's continued commitment and foresight is critical in DoD's efforts to protect the warfighter from the devastating toxic effects of radiation exposure. There is currently no Food and Drug Administration (FDA) approved countermeasure for exposure to total body irradiation and the research sponsored by this contract supports our collaborative efforts to advance CBLB502 towards a Biologic License Application (BLA) to fulfill this unmet need."
About CBLB502
CBLB502 is a bio-engineered 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. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic, and biomarker testing in healthy human subjects.
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 healthy human subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was generally well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of lethal total body irradiation. Top line data from a second safety and tolerability study in 100 healthy subjects demonstrated that administration of CBLB502 resulted in a rapid and potent cytokine response, similar to that seen in the prior clinical trial and in previously conducted non-human primate studies, and that CBLB502 was generally well tolerated.
CBLB502 was granted Fast Track and Orphan Drug designations from the FDA for reducing the risk of or preventing death following total body irradiation during or after radiation disaster. The FDA Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Such programs include expanded communications (both verbal and written), rolling BLA submission and reviews, priority review (6 month action date instead of 10 month action date) and accelerated drug approval (approval on the basis of a surrogate endpoint). The FDA orphan drug program provides incentives for sponsors to develop products for rare diseases. Such incentives include extended marketing exclusivity, waiver of BLA filing user fees, grant funding to defray the cost of clinical testing, tax credits for the costs of clinical research and assistance in clinical research study designs.
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.
These factors include, among others, the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts; the Company's failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company's ability to comply with various safety, environmental and other governmental regulations. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.
Contact:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com