Contact Information: Contacts: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Recaps Development of Lead Compounds and Affirms Confidence in Competitive Position for Department of Defense Contract
Company to Host Year-End Update Conference Call December 17 at 10:00 a.m. EST
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - December 13, 2007) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ), today
announced that it will host a conference call to update investors on the
progress of its clinical programs, research and development efforts,
corporate developments, and the status of the Company's pending contract
with the Department of Defense (DoD).
Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland
BioLabs, stated, "As we approach the end of 2007, we are pleased with the
advances we have made across all of our lead programs. We have achieved
several major milestones on time and in line with our expectations. Our
lead anticancer compound, Curaxin CBLC102, reached all of the technical
benchmarks defined by the FDA in its first Phase II study. We have already
launched a second Phase II and will be starting a third early next year.
We continue our research and development efforts, which will bring our
innovative tissue protecting drugs, Protectans, into clinical trials for
medical use in 2008. Our stem cell program received a boost when we
demonstrated that our leading molecule drastically outperformed a
multi-billion dollar drug from a major biotechnology player, in a mouse
model. On the corporate front, we have established a strategic research
partnership with Roswell Park Cancer Institute (RPCI), a world-renowned
cancer research hospital and the nation's first cancer research, treatment
and education center. Our new dedicated facility on RPCI's medical campus
will become the foundation for our advanced research and clinical trials.
"In addition, we remain confident that we are in a very strong competitive
position to receive a significant contract from the DoD for our lead
Protectan, CBLB502. Our estimation of receiving a decision and potential
award from the DoD by the end of 2007 was based on the rapid pace of our
multiple interactions and negotiations, which were concluded at the end of
September, and left us with a highly positive impression. We expect the
contract at any time in the near future. In the mean time, we are moving
ahead with Protectan CBLB502's development for defense and medical uses and
plan to initiate Phase I human safety trials, the only stage of human
testing required by the FDA for approval in radiation protection for
defense use, in early 2008."
The Company has announced several updates on its lead compounds over the
past quarter:
On October 18, Cleveland BioLabs announced the completion of Good
Manufacturing Practices compliant (cGMP) manufacturing of Protectan
CBLB502. Dr. Fonstein noted that the Company currently has drug substance
corresponding to over 100,000 projected human doses, or potentially many
more, depending on the final therapeutic dose to be used, which will be
determined through the Phase I safety trial.
Cleveland BioLabs 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.
On November 26, CBLI announced the initiation of a Phase II efficacy study
for Curaxin CBLC102 in advanced renal cell carcinoma (a highly fatal form
of kidney cancer). Curaxin CBLC102 is currently in an ongoing Phase II
trial in hormone refractory prostate cancer and an additional Phase II
study of Curaxin CBLC102 in multiple cancer types is planned for early
2008.
On December 4, the Company shared 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. Fonstein said that this was the first primate study pointing towards
CBLB502's 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. The Company believes that it has a very strong position in the
anticipated competition for radiation countermeasures for the protection of
the general population initiated by HHS.
In a Request for Information (RFI) published earlier this year, the
Department of Health and Human Services (HHS) 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.
On December 12, CBLI announced results of a study of the effects of
Protectan CBLB612, on propagation and mobilization to peripheral blood of
hematopoietic stem cells (HSC) in comparison with G-CSF, the current market
leading product, in mice.
Direct comparisons of CBLB612 and G-CSF, injected as single agents or in
combination with AMD3100, a promising clinical-stage stem cell mobilizer,
demonstrated much stronger efficacy of CBLB612 as a stimulator and
mobilizer of HSC in peripheral blood. These results indicate a potential
breakthrough for minimally invasive and more effective blood stem cell
collection.
The Company will host a conference call to update investors on all of these
developments on Monday, December 17, at 10:00 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 December 17, 2007, at
1:00 p.m. Eastern Standard Time through December 24, 2007 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 266260. 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 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.