September 23, 2008
Cleveland BioLabs to Present Protectan CBLB502 at 2008 BARDA Day
Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today that it will present Protectan CBLB502 at the 2008 Biomedical Advanced Research and Development Authority (BARDA) Stakeholders Workshop and Industry Day, September 24-26, in Washington, DC.
Cleveland BioLabs Chief Scientific Officer, Andrei Gudkov, Ph.D., D. Sci., has been invited to speak on Wednesday, September 24, at the Radiological and Nuclear Therapeutics Session. His presentation, titled "Protectan CBLB502 Prevents and Mitigates Hematopoietic and Gastrointestinal Acute Radiation Syndromes by Mobilizing Multiple Natural Defense Mechanisms," will highlight Protectan CBLB502's demonstrations of efficacy and multiple mechanisms of action, some of which were featured in a peer review publication in the April 11 issue of Science.
In addition, Vadim Krivokrysenko, Ph.D., Protectan CBLB502 Project Leader at Cleveland BioLabs, will exhibit a poster summarizing recent non-human primate studies with Protectan CBLB502 titled, "Single Injection of Novel Radioprotector CBLB502 Rescues Lethally Irradiated Non-Human Primates."
The goal of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2008 and BARDA Industry Day is to provide an open forum for Government officials, pharmaceutical and biotechnology industry representatives, state and local first responders, public health advocates, academicians, and other key stakeholders to share ideas for advancing public health preparedness in a collaborative environment
Cleveland BioLabs was recently awarded a development contract from BARDA for selected tasks in the advanced development of Protectan CBLB502. The total contract value including all milestone-based options is $13.3 million over a three-year period, with the first year's award of $3.4 million, commencing September 16, 2008. Earlier this year, the Company was awarded an $8.9 million development contract for Protectan CBLB502 from the Department of Defense. The combination of these two awards is expected to support the final stages of Protectan CBLB502's development necessary for submission for FDA approval.
Cleveland BioLabs has successfully established cGMP quality manufacturing for Protectan CBLB502, demonstrated preclinical efficacy and safety of this product and recently received an allowance from the FDA to begin Phase I clinical trials in human volunteers. Protectan CBLB502 is being developed under the FDA's animal efficacy rule to treat radiation injury following exposure to radiation from nuclear or radiological weapons, or from nuclear accident. This approval pathway requires demonstration of efficacy in two animal species and safety and drug metabolism testing in a representative sample of healthy human volunteers.
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. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" 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: [email protected]
SOURCE: Cleveland BioLabs, Inc.