Contact Information: Contacts: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Achieves Recovery From Neutropenia and Thrombocytopenia in Primates 48 Hours Post-Irradiation With Protectan CBLB502
Demonstrates Potential for Radiation Antidote Stockpiling
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - December 4, 2007) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced results of a primate study demonstrating the efficacy of
Protectan CBLB502 as a mitigator of hematopoietic (bone marrow/blood
production) damage up to 48 hours post-radiation exposure.
Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland
BioLabs, commented, "Protectan CBLB502's strong mitigation of both
gastrointestinal and hematopoietic radiation-induced damage have been well
documented, warranting its potential use for military personnel and first
responders. This is the first primate study pointing towards its high
utility in protection of civil populations, where countermeasures would be
stockpiled and then distributed, implying substantial delays and requiring
efficacy many hours after the event of radiation. We now have a very
strong position in the coming competition for radiation countermeasures for
protection of general population initiated by the Department of Health and
Human Services (HHS)."
Acute Radiation Syndrome (ARS), also referred to as radiation sickness, is
an acute illness caused by irradiation of the entire body (or most of the
body) by a high dose of penetrating radiation in a relatively short time
period. Such exposure can result in the depletion of hematopoietic stem
cells and progenitors, leading to severe neutropenia (low levels of
neutrophils, a type of white blood cell) and thrombocytopenia (low platelet
count). Severe neutropenia increases the risk of sepsis and death due to
opportunistic infections, while thrombocytopenia increases the risk of
hemorrhage and death due to bleeding. Both conditions are likely to be
major contributors to mortality in untreated individuals exposed to doses
of radiation that affect the hematopoietic system.
In the Company's recent experiment, five groups of 10 rhesus primates
received 5 Gy (approximately 20% lethal dose) of gamma radiation. The
control group received a placebo, while the four experimental groups
received a single intramuscular injection of Protectan CBLB502 at one of
the following times: 1, 16, 24 or 48 hours after irradiation.
No mortality was observed in CBLB502-treated groups after 30 days, while
20% mortality was observed in the control group.
The duration and occurrence of severe thrombocytopenia was strongly reduced
by CBLB502. The average number of severe thrombocytopenia ( < 50,000
platelets/ul) days per monkey was drastically reduced from 4.3 in control
group to 0.6-1.5 in all four CBLB502-treated groups. Thrombocytopenia has
been shown to be the best predictor of primate post-irradiation mortality
in recent studies.
In addition, duration and occurrence of severe neutropenia was also reduced
by CBLB502. For example, an average number of days of extremely severe
neutropenia ( < 100 neutrophils/ul) per monkey was reduced from 2.7 in
control group to 0.3-1.5 in experimental groups.
Protectan CBLB502 is undergoing an accelerated development program under
the FDA two-animal rule, which requires demonstrations of efficacy in two
animal species and only safety in humans. The Company recently announced
the completion of Good Manufacturing Practices compliant (cGMP)
manufacturing of Protectan CBLB502 and plans to submit an Investigational
New Drug (IND) application to the FDA for a human safety study this year.
Cleveland BioLabs submitted Protectan CBLB502 in response to a Request for
Information (RFI) from HHS in July 2007, which noted the agency's intention
to pursue initial acquisition of 100,000 treatment courses of a medical
countermeasure for neutropenia arising as a consequence of ARS. The RFI
further stated that there would be options for up to an additional 100,000
treatment courses to meet the US Government's requirement of at least
200,000 treatment courses.
Cleveland BioLabs also submitted CBLB502 to the Department of Defense (DoD)
in response to a 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, leading to purchase of up to 500,000
doses, thereafter. The Company expects the DoD to make its decision on the
RFP this year.
Medical applications for Protectan CBLB502 include reduction of radiation
therapy side effects in cancer patients and ischemic diseases involving
lack of blood flow to certain parts of body such as acute organ failure,
heart disease and stroke.
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, 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 periodic filings with the Securities and
Exchange Commission.