CLEVELAND, Dec. 1 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc.
Dr. Yakov Kogan, Executive Vice President of Cleveland BioLabs commented, "Given the increasing threat and incidence of radiation exposure to both military personnel and civilians in today's society, development of compounds to protect against the most damaging effects of ARS is critical. The DoD's request has reinforced the importance of protecting the gastrointestinal tract, in addition to the hematopoietic (immune) system; and we believe that our Protectan CBLB502 offers unique advantages over other therapeutics through its ability to protect both systems before and after exposure."
The Company's response included several features of Protectan CBLB502 as both a radioprotectant and mitigator of radiation exposure: CBLB502 is effective as a radioprotectant when administered as little as 15 minutes prior to exposure and as a mitigator, if administered up to one hour after exposure. In addition, CBLB502 is stable in solution and powder form, so it can be quickly dissolved and injected using self-injectable devices, which are the preferred delivery system in the field. Moreover, the compound does not display toxicity at therapeutic doses.
Research has demonstrated that a single injection of less than 1% of the maximum tolerable dose of CBLB502 rescues greater than 80% of NIH Swiss mice from as high as 13 Gy of total body irradiation. Other known compounds in development show no protective effect from this level of radiation exposure. CBLB502 also showed strong radioprotective efficacy as a single therapy in non-human primates, enabling survival of 70% of the animals that received whole-body radiation, versus the control group, in which 75% of the animals died.
Of those monkeys in the control group that survived, none were without significant abnormalities, suggesting that long-term deleterious effects from the radiation were likely. In contrast, surviving monkeys treated with CBLB502 possessed no significant structural abnormalities in bone marrow, immune system organs, or small intestines at the 40-day mark. This is consistent with data obtained from mice. Irradiated mice treated with CBLB502 survived the duration of their remaining normal life span without development of any significant abnormalities and preserving normal formation of blood cells (hematopoiesis). This data suggests that CBLB502 offers true protection from gamma-irradiation induced ARS, including the lethal effects on both gastrointestinal and hematopoietic systems.
CBLB502 is undergoing an accelerated development program under the FDA two-animal rule, which requires the Company to show efficacy in two animal species (including primates) and only safety in humans.
The Sources Sought Notice called for Prime Contractor(s) for advanced development activities associated with therapeutic products to either prevent or reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation or restoration of the anatomic integrity and normal physiologic functioning of the gastrointestinal tract. These therapeutic products are being developed in response to a requirement to treat Armed Forces service members for the effects of radiation injury and to allow commanders to sustain and continue operations in the event of nuclear or radiological attacks on U.S. Forces.
The Department of Defense's Sources Sought Notice can be publicly accessed from the following URL:http://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M07S0001/SynopsisR.html.
About Cleveland BioLabs, Inc.
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 Foundation, ChemBridge Corporation and the Armed Forces Research Radiobiology 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 that reflect our current view with respect to various aspects of the events described above. Actual results could be significantly different. Factors that could affect results include those set forth in filings made by Cleveland BioLabs, Inc. with the Securities and Exchange Commission. These factors include, but are not limited to, those discussed in our Registration Statement on Form SB-2 under the caption "Risk Factors."
Contact:
The Global Consulting Group
Rachel Levine
T: (646) 284-9439
E: rlevine@hfgcg.com