BUFFALO, NY--(Marketwire - May 23, 2011) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today that it has received a Notice of Allowance from the Japan Patent Office for a CBLB502 patent application. Allowed claims cover the method of protecting a mammal from radiation using flagellin or its derivatives, including CBLB502.
Yakov Kogan, Ph.D., MBA, Chief Operating Officer of Cleveland BioLabs, stated, "This Notice of Allowance expands validation of our claims regarding protection from radiation with CBLB502 and other flagellin derivatives in major jurisdictions worldwide including the United States, Europe, Eurasia, China, and now Japan. We remain focused on advancing CBLB502 towards a biologic license application with the FDA."
CBLB502 is a rationally-designed, 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 to reduce the risk of or prevent death following total body irradiation during or after radiation disaster. 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 150 healthy human subjects in two clinical safety and tolerability studies indicated that administration of CBLB502 resulted in a rapid and potent cytokine and hepatic immunologic response, similar to that seen in previously conducted non-human primate studies. The most frequent adverse event associated with CBLB502 administration was a transient flu-like syndrome, which generally resolved within 24 hours.
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.