Contact Information: Contacts: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Not Selected for Defense Contract Award
Company to Host Conference Call to Discuss Ongoing Development Strategy for Pipeline of Compounds
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - January 4, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that it was informed by the Department of Defense (DoD) that
Protectan CBLB502, the Company's candidate for the treatment of
gastrointestinal (GI) effects of acute radiation syndrome was not selected
for award under the request for proposal (RFP) No. W9113M-07-R-0002,
entitled, "Medical Radiation Countermeasures Development and Delivery."
The Company is very surprised by the DoD's decision and has requested a
debriefing in order to better understand the DoD's decision. In June 2007,
based on the DoD's evaluation of the Company's technical and cost proposal,
the DoD informed the Company that its proposal for Protectan CBLB502 was
within the competitive range and invited Cleveland BioLabs for a
face-to-face meeting on July 26, at which the details of the Company's
proposal were discussed. The DoD reaffirmed this positive feedback in
September 2007, when it requested an additional amendment asking for an
increased development budget, as well as up to 1.5 million doses of a self
or
buddy-administered countermeasure for use in the battlefield.
Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland
BioLabs stated, "Given the aggressive nature and degree of detail of the
DoD's responses and ensuing negotiations regarding our proposal, we are
deeply disappointed by this unexpected decision. We intend to further
develop CBLB502 and seek FDA approval and will respond to future DoD
solicitations as they are announced. Cleveland BioLabs' research has
demonstrated CBLB502's unique ability to mitigate the damaging effects of
ionizing radiation on all major acute radiation syndromes, including
gastrointestinal, as well as to demonstrate significant survival benefits.
In addition, the compound's safety profile, stability and method of
administration make it highly practical for field deployment, both for
military and civilian populations."
Cleveland BioLabs Chief Scientific Officer, Andrei Gudkov, Ph.D, D. Sci.,
said, "We believe our Protectan CBLB502 is quite unique in three particular
areas with strong supporting data: The first is prolonged survival or
long-term survival benefits, which we have demonstrated in both mice and
primates; the key FDA requirements for drug approval under the two-animal
efficacy rule. The second is protection of the GI tract, which we have
demonstrated in two animal species. The third is its remarkable stability,
a significant shelf life and its suitability for easy self and
buddy-administration in battlefield, civilian or hospital conditions.
Moreover, the technology we developed for CBLB502 allowed cost-effective
production of over 100,000 doses per manufacturing batch under cGMP
conditions, which could provide protection for the numbers of military
forces potentially exposed to radiation from tactical nuclear weapons in
the field or terrorist attacks directed against civilian populations."
"We remain committed to developing Protectan CBLB502 for both defense and
medical uses," added Dr. Gudkov. "We plan to continue our discussions with
the Department of Health and Human Services and other friendly governments,
who are interested in its potential to protect against terrorist threats
and nuclear disaster. Our goal is to achieve FDA approval for CBLB502 in
2009 and market it as an effective and affordable radiation protector for
defense use on the battlefield or in first responder or civilian
emergencies."
Protectan CBLB502 is undergoing an accelerated development program under
the FDA two-animal rule for defense, which requires demonstrations of
efficacy in two animal species and only safety in humans. As planned, the
Company will submit an Investigational New Drug application to the FDA for
a human safety study shortly.
The Defense Threat Reduction Agency of the DoD awarded Cleveland BioLabs a
grant in March 2007, to fund 'development leading to the acquisition' of
Protectan CBLB502 as a radiation countermeasure, in collaboration with the
Armed Forces Radiobiology Research Institute, which has also received
significant independent funding for work on Protectan CBLB502. The DoD
also recently awarded a $1 million grant to the Company's founding partner,
the Cleveland Clinic, to conduct pre-clinical studies on Protectan CBLB502
for use in tourniquet and other ligation-reperfusion battlefield injuries
where blood flow is stopped and then restored after a prolonged period of
time.
Potential medical applications for CBLB502 are broad and include reduction
of radiation therapy side effects in cancer patients, and ischemic diseases
such as acute organ failure, heart disease and stroke. Protectan CBLB502
has shown efficacy as a potential adjuvant for radiation therapy in mouse
models of sarcoma and Company researchers in collaboration with
investigators from Cleveland Clinic have demonstrated that a single
injection of Protectan CBLB502 effectively prevents acute renal failure and
subsequent death in a mouse model of ischemia-reperfusion renal injury.
Cleveland BioLabs' scientific platform has yielded several other compounds
in addition to Protectan CBLB502. These include other tissue protecting
drugs, Protectans, as well as anticancer compounds, Curaxins. Among the
more advanced of these compounds is Curaxin CBLC102, an orally administered
small molecule designed to kill tumor cells in Phase II trials, and
Protectan CBLB612, which has demonstrated strong potential efficacy as a
stimulator and mobilizer of hematopoietic stem cells in peripheral blood.
The Company will host a conference call to discuss the DoD decision and its
ongoing development strategy today at 8:30 a.m. Eastern Standard Time.
Interested parties may participate by dialing 877-407-8033 (US) or
201-689-8033 (International) approximately five to ten minutes before the
call start time. A live Webcast of the conference call will be available
on the Cleveland BioLabs Web site at www.cbiolabs.com.
A replay of the call will be available starting on January 4, 2008, at
12:00 p.m. Eastern Standard Time through January 11, 2008 at 11:59 p.m.
Eastern Standard Time. Interested parties may access the replay by dialing
877-660-6853 (US) or 201-612-7415 (International) and entering account
number 286 and conference ID number 268331. An archived Webcast of the
conference call will be available on the Cleveland BioLabs Web site at
www.cbiolabs.com.
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 Radiobiology Research 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.