NASA SBIR 2003 Solicitation

FORM B - PROPOSAL SUMMARY


PROPOSAL NUMBER:03-B3.06-8344 (For NASA Use Only - Chron: 034661)
SUBTOPIC TITLE:Radiation Shielding to Protect Humans
PROPOSAL TITLE:New class of biological radioprotectors

SMALL BUSINESS CONCERN (Firm Name, Mail Address, City/State/Zip, Phone)
Cleveland BioLabs, Inc.
10265 Carnegie Avenue
Cleveland ,OH 44106 - 2130
(773) 517 - 7282

PRINCIPAL INVESTIGATOR/PROJECT MANAGER (Name, E-mail, Mail Address, City/State/Zip, Phone)
Pavel G Komarov
cbiolabs@cbiolabs.com
10265 Carnegie Avenue
Cleveland ,OH  44106 -2130
(440) 461 - 8772
U.S. Citizen or Legal Resident: Yes

TECHNICAL ABSTRACT (LIMIT 200 WORDS)
Space radiation is the major risk to the astronauts outside the Earth magnetosphere that cannot be eliminated by the existing radioprotectors. The ultimate goal of this proposal is to develop a new class of pharmacological agents for protection against space radiation using a new source of natural products ?potent cell survival factors produced by endosymbiotic and parasitic microorganisms. Induction of programmed cell death (apoptosis) occurring in radiosensitive tissues is one of the major determinants of radiation-induced failure of hematopoietic and digestive systems and other pathologies, including pathological changes in the nervous system. As a part of their survival strategy, endosymbiotic and parasitic microorganisms evolved to produce powerful anti-apoptotic factors suppressing cell death in infected tissues; such factors were found to be effective radioprotectors. CBLB-501 protein isolated from Salmonella belongs to this category; it provides complete rescue of mice from lethal doses of gamma radiation causing hematopoietic and gastrointestinal syndromes. The proposed program is aimed at developing CBLB-501 into a useful radioprotective agent. It includes: a) evaluation of the radioprotective properties of CBLB501 in the animal model system; and optimization of treatment regimens, (b) development of optimized structural derivatives of CBLB-501, and (c) design and evaluation of combinatorial therapies employing CBLB501 together with most efficient conventional radioprotectors.

POTENTIAL NASA COMMERCIAL APPLICATIONS (LIMIT 150 WORDS)
CBLB-501 and related inhibitors of cell death will be useful as protectors against both acute and prolonged low-level irradiation. CBLB-501 has already been shown to be a powerful radioprotector. The resulting pharmaceuticals are expected to be used as anti-radiation antidotes in space missions. They will likely to be also useful in combination with the existing set of bioprotective measures (such as dietary antioxidants/free radical scavengers and cytokines) by complementing their mechanisms of action and dramatically increasing tolerable radiation doses.

POTENTIAL NON-NASA COMMERCIAL APPLICATIONS (LIMIT 150 WORDS)
The projected market for the new class of inhibitors of cell death in biopharmaceutical industry is broader than radioprotection. They can be used for treatment or prevention of other life-threatening injuries that involve the massive cell death, and therefore potentially treatable with CBLB501, including cancer treatment side effects caused by chemo- and radiotherapy, stroke, acute inflammation, myocardial infarction, as well as nuclear and chemical accidents.