BUFFALO, NY--(Marketwire -10/24/11)- Cleveland BioLabs, Inc. (NASDAQ: CBLI - News) today announced pre-publication of a study demonstrating CBLB502's ability to both protect from local radiation toxicity and to inhibit tumor growth in mouse tumor models. The study was conducted by scientists at Cleveland BioLabs and Roswell Park Cancer Institute and is available online in the International Journal of Radiation Oncology, Biology and Physics (doi:10.1016/j.ijrobp.2011.05.055).
Protection against local radiation was demonstrated in a head and neck cancer model utilizing syngeneic squamous cell carcinoma SCCVII. Mice received either single-dose or fractioned irradiation of the head and neck area with or without subcutaneous injection of CBLB502 administered 30 minutes prior to irradiation. CBLB502 significantly reduced the severity of dermatitis and mucositis, accelerated tissue recovery and reduced the extent of radiation induced weight loss after a single dose of up to 20Gy. CBLB502 was also protective from cumulative doses up to 30Gy delivered in two or three fractions, respectively. While providing protection to normal oral epithelium, CBLB502 did not affect the radiosensitivity of the squamous cell tumors.
CBLB502 was also shown to elicit a radiation independent growth inhibitory effect upon TLR5-expressing human lung adenocarcinoma A549 in a mouse xenograft model. Thus, in these mouse models, treatment with CBLB502 was shown to reduce toxicity from local radiotherapy and to have radiation-independent anticancer activity, with both of these activities being mediated via activation of TLR5 signaling in normal epithelium or tumor tissue respectively.
Andrei Gudkov, Ph.D., D.Sc., Chief Scientific Officer of Cleveland BioLabs, and Senior Vice President of Basic Science at Roswell Park Cancer Institute, commented, "While the efficacy of CBLB502 as a radiation countermeasure in the context of total body irradiation has been well characterized in animal models, this work provides the first demonstration of CBLB502's radioprotective efficacy in a model of localized irradiation of cancer and shows that it has direct anticancer activity as well. It is conceivable that CBLB502 might ultimately find application as a single agent that possesses both radioprotective and therapeutic anticancer activities. We have been working closely with oncologists to develop clinical protocols through which we will evaluate the potential radioprotective effects of CBLB502 in patients and plan to initiate such a trial in head and neck cancer patients."
The work cited in the publication was supported by grants from the National Institutes of Health.
The International Journal of Radiation Oncology, Biology and Physics publication may be found online at: http://www.redjournal.org/article/S0360-3016(11)02802-1/fulltext.
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 relationships 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 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 and its ability to win additional funding under such 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.