CLEVELAND, April 9 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc.
In the study, Rhesus monkeys were irradiated with 6.5 Gy of total body irradiation and injected intramuscularly with either a single dose of Protectan CBLB502 or a placebo, one hour after irradiation. No supportive therapy was applied. The animals were observed for 40 days. CBLB502 enabled survival of 70% of the animals in the protected group, versus the control group, in which 20% of the animals survived. In addition, gross pathology results showed that the majority of control animals displayed severe damage to the GI tract, while the CBLB502 treated animals did not. This data demonstrates CBLB502's capacity as a mitigator of gastrointestinal radiation-induced injury.
Dr. Gudkov commented, "The level of protection observed in this study is very impressive and we are gratified to see that it is as high as the level achieved when Protectan CBLB502 is administrated one hour prior to irradiation. This confirms our previously achieved results in mitigation of radiation damage in rodents. CBLB502 is the first compound to provide protection from both gastrointestinal and hematopoietic radiation-induced damage when administrated before or after irradiation. Moreover, mitigation shown in two animal species opens much broader potential markets for CBLB502's use as a radiation antidote."
The Company is submitting Protectan CBLB502 to the Department of Defense (DoD) in response to a recently published Request for Proposal (RFP) for medical radiation countermeasures to treat gastrointestinal effects of acute radiation syndrome. The RFP award would provide funding for development of the countermeasure through FDA approval, as well as a commitment to purchase up to 500,000 doses, thereafter.
Protectan CBLB502 is undergoing an accelerated development program under the FDA two-animal rule, which requires the Company to show efficacy in two animal species and only safety in humans. Cleveland BioLabs is in the process of completing Good Manufacturing Practices compliant (cGMP) manufacturing of Protectan CBLB502 and plans to submit an Investigational New Drug (IND) application for a human safety study later this year.
Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein, Ph.D., added, "The radio-protective properties of Protectan CBLB502 are specific to healthy, non-cancerous tissues, making CBLB502 a promising candidate to treat side effects of cancer patients undergoing radiation therapy and potentially, chemotherapy. The National Cancer Institute reports that for every $1 spent on cancer treatments, approximately $0.70 is spent on supportive care to counteract the side effects of treatment. We believe this could be a significant potential follow-on market for CBLB502."
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, Roswell Park Cancer Institute, 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 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. Our 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 our filings with the Securities and Exchange Commission.
Contacts:
The Global Consulting Group
Rachel Levine
T: (646) 284-9439
E: rlevine@hfgcg.com