Cleveland BioLabs Doses First Healthy Volunteer In Initial Safety Study For Protectan CBLB502

Main Category: Bio-terrorism / Terrorism
Also Included In: Clinical Trials / Drug Trials;  Endocrinology;  Radiology / Nuclear Medicine
Article Date: 21 Oct 2008 - 3:00 PDT

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Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced that on October 14, the first healthy volunteer was dosed in the initial human safety study for Protectan CBLB502, a drug under development for the treatment for Acute Radiation Syndrome (ARS).

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 representative animal models and safety and drug metabolism testing in a representative sample of healthy human volunteers. Cleveland BioLabs has successfully established cGMP quality manufacturing for Protectan CBLB502, and demonstrated pre-clinical activity of this product in animal models of ARS.

This initial safety study will involve single injections of Protectan CBLB502 in ascending dose groups of six healthy volunteers each. Participants in the study will be assessed for adverse side effects over a two-week time period and blood samples will be obtained to assess the effects of Protectan CBLB502 on various biomarkers. The study is currently projected to take approximately six months to complete and would be followed by a second, larger safety study in healthy human volunteers, prior to submission of a Biologic License Application (BLA) to the FDA.

Cleveland BioLabs received two development contracts totaling $22.2 million from the Biomedical Advanced Research and Development Authority (BARDA) of the of the Department of Health and Human Services (DHHS) and the Department of Defense (DoD) for the advanced development of its lead tissue protection compound, Protectan CBLB502, as a radiation countermeasure. These two awards are expected to support the final stages of Protectan CBLB502's development necessary for submission to the FDA for approval.

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.

Cleveland BioLabs, Inc