Chief Scientist to Present Results at 2007 American Association for Cancer
Research Annual Meeting
First Compound to Protect from both Gastrointestinal and Hematopoietic
Damage when Administrated before or after Irradiation
CLEVELAND, April 9 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc.
(Nasdaq: CBLI; BSE: CFB), announced today the results of its study of
Protectan CBLB502's efficacy as a mitigator of both gastrointestinal (GI)
and hematopoietic (bone marrow/blood production) radiation-induced damage
in non-human primates. The Company's Chief Scientific Officer, Andrei
Gudkov, Ph.D, D. Sci., will present results of the study at the 2007
American Association for Cancer Research (AACR) Annual Meeting, April
14-18, in Los Angeles, CA.
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
SOURCE Cleveland BioLabs, Inc.
 back to top
Related links:
http://www.cbiolabs.com
CONTACT:
Rachel Levine of The Global Consulting Group,
+1-646-284-9439, rlevine@hfgcg.com, for Cleveland BioLabs, Inc.
|
