Contact Information: Contacts: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs CEO to Share Ongoing Development Strategy at BIO CEO and Investor Conference
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - February 7, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that the Company is scheduled to present at the 2008 BIO CEO and
Investor Conference to be held February 11-13, in New York City. Cleveland
BioLabs management will be available for meetings in New York City during
the conference.
Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland
BioLabs, will give a presentation on the Company's lead compounds and
development strategy on February 12, at 3:30 p.m. ET. The presentation
will be broadcast live over the Internet. Interested parties may tune in
to the live presentation by visiting the Investor Information section of
the Company's website at: www.cbiolabs.com.
"We continue to develop our lead compounds for both medical and defense
applications, while we are in the midst of the Department of Defense
debriefing process. We are also pursuing opportunities to work with the
U.S. and other governments on various radiation protection initiatives,"
stated Dr. Fonstein.
Cleveland BioLabs' pipeline includes products from two primary families of
compounds: Protectans are being developed as drug candidates that protect
healthy tissues from acute stresses such as radiation, chemotherapy and
ischemia (conditions in which blood flow, and thus oxygen, is restricted to
a part of the body). Curaxins are being developed as anticancer agents
that could act as mono-therapy drugs or in combination with other existing
anticancer agents.
One of the Company's lead compounds, Protectan CBLB502, is a modified
microbial protein that temporarily protects cells from regulated cell death
and enables them to repair damage acquired through acute stresses.
Potential applications for CBLB502 are broad and include reduction of
radiation therapy or chemotherapy side effects in cancer patients,
protection from Acute Radiation Syndrome (ARS) in defense scenarios, and
protection from acute organ failure.
Protectan CBLB502 is the first compound of its kind to provide protection
from both gastrointestinal and hematopoietic (bone marrow/blood production)
radiation-induced damage. The Company intends to initiate a Phase I human
safety study in the first half of 2008 for CBLB502 in ARS, which is the
final stage of human testing required for approval in this indication. At
the same time, Cleveland BioLabs plans to initiate a Phase I/II study for
CBLB502 in head and neck cancer patients for reduction of side effects of
radiation and chemotherapy, such as mucositis, which is a
treatment-limiting factor.
Protectan CBLB612 is a modified lipopeptide mycoplasma that acts as a
powerful stimulator and mobilizer of hematopoietic stem cells (HSC) to
peripheral blood. Potential applications for CBLB612 include accelerated
hematopoietic recovery during chemotherapy, as well as during donor
preparation for bone marrow transplantation. With efficacy and non-GLP
safety already studied in mice and monkeys, CBLB612 will enter formal
pre-clinical safety and manufacturing development in February 2008. Its
first human trials are projected for early 2009.
Direct comparisons of Protectan CBLB612 and the market leading drug for
propagation and mobilization of HSC to peripheral blood, G-CSF, injected as
single agents or in combination with AMD3100, demonstrated much stronger
efficacy of CBLB612 as a stimulator and mobilizer of HSC in peripheral
blood.
Cleveland BioLabs has ongoing collaborations with the Armed Forces
Radiobiology Research Institute (AFRRI) and the Defense Threat Reduction
Agency of the Department of Defense for the development of both Protectan
CBLB502 and Protectan CBLB612.
The most advanced product candidate in the Curaxin family is CBLC102, an
orally administered small molecule designed to kill tumor cells. The
Company has an ongoing Phase II trial with CBLC102 in hormone refractory
prostate cancer and expects to report the results of this trial in the fist
half of 2008. CBLC102, discovered in an anti-cancer screening assay is an
old, discontinued drug, quinacrine, formerly used against malaria. Its
further development will include testing against other cancers, as well as
clarifying its potential use in prostate cancer through further dose
escalation studies.
An entirely proprietary next generation of Curaxins has been created
through extensive hit-to-lead optimization, which has provided potentially
improved efficacy and a broader therapeutic window. Since these are new
molecular entities, they are patentable as composition-of-matter. These
new Curaxins are entering formal pre-clinical safety and manufacturing
development. Their first human trials are projected for early 2009.
"We have an exciting and robust pipeline of compounds based on our unique
approach to drug discovery," concluded Dr. Fonstein. "We look forward to
sharing our progress and milestones as we create value for all of our
stakeholders."
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. The
Company's 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 the Company's periodic filings with the
Securities and Exchange Commission.