Cleveland BioLabs Breakthrough Protects From Radioation

Armen Hareyan's picture
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Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that Science, the world's leading journal of original scientific research, global news, and commentary, has published breakthrough findings by Cleveland BioLabs researchers regarding Protectan CBLB502's radioprotective abilities, titled, "An Agonist of Toll-Like Receptor 5 Has Radioprotective Activity in Mouse and Primate Models." Cleveland BioLabs's paper is the first Science publication on radioprotection in more than three decades.

The peer-reviewed paper introduces a novel principle of radioprotection, which resulted in generation of a radioprotectant of unprecedented efficacy, CBLI's lead product Protectan CBLB502. The report summarizes studies of Protectan CBLB502's ability to protect healthy cells from the harmful effects of radiation. According to experimental findings, a single injection of CBLB502 before lethal total-body irradiation protected mice from both gastrointestinal and hematopoietic acute radiation syndromes and resulted in improved survival. CBLB502 injected after irradiation also enhanced survival. The paper noted that the drug did not decrease tumor radiosensitivity in mouse models. CBLB502 also showed radioprotective activity in lethally irradiated rhesus monkeys.

Cleveland Biolabs Chief Scientific Officer and co-corresponding author, Andrei Gudkov, Ph.D, D. Sci., commented, "We consider this paper a breakthrough for the study of radioprotection, since it provides a long awaited example of single agent anti-radiation therapy with significant survival benefits at a single dose. Described experiments demonstrate its potential therapeutic benefit in both cancer radiotherapy and radiation emergency scenarios. The paper also provides results indicating safety of CBLB502, which protects animals without increasing the risk of radiation-induced cancer development. This is the Company's first major publication on our proprietary Protectan family of compounds, which are derived from naturally occurring factors of microbes found in our bodies."

The Department of Defense recently awarded Cleveland BioLabs a contract valued at up to $8.9 million for the advanced development of Protectan CBLB502 as a Medical Radiation Countermeasure to treat radiation injury following exposure to radiation from nuclear or radiological weapons.

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"The Science paper demonstrates the success of the principle proprietary approach of CBLI to protection of healthy tissue from a variety of deadly stresses," added Dr. Gudkov. "The remarkably strong radioprotective abilities of Protectan CBLB502 are the result of a combination of several mechanisms of action, each of which is substantially effective on its own."

Protectan CBLB502 is a derivative of a microbial protein that reduces injury from acute stresses by mobilizing several natural cell protecting mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration promoting cytokines.

Cleveland BioLabs has successfully established cGMP quality manufacturing for CBLB502 and plans to initiate its first Phase I human safety study in the first half of 2008 for Protectan CBLB502 in ARS, which is the only stage of human testing required for approval in this indication. Concurrently, the Company plans to initiate a Phase I/II study for CBLB502 in head and neck cancer patients for reduction of side effects of radiation and chemotherapy, such as mucositis, which is a treatment-limiting factor.

An abstract of the article will be available online at: www.sciencemag.org/current.dtl

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect 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 www.cbiolabs.com.

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