Cleveland BioLabs and Incuron Announce Notice of Allowance From FDA to
Commence Clinical Testing With CBL0137
BUFFALO, N.Y., April 2, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc.
(Nasdaq:CBLI) and Incuron, LLC, a joint venture between the Company and
Bioprocess Capital Ventures, today announced the receipt of a Notice of
Allowance from the U.S. Food and Drug Administration (FDA) for an
Investigational New Drug (IND) application for CBL0137.
A multi-center, Phase 1, single agent, dose escalation trial evaluating
intravenous administration of CBL0137 in patients with metastatic or
unresectable advanced solid cancers is being finalized with the FDA. The
primary objective of the study is to determine the maximally tolerated dose
and recommend a Phase 2 dose for CBL0137 in these patients. Secondary
objectives include describing the dose limiting toxicity, adverse event and
pharmacokinetic profile of CBL0137, as well as documenting any objective
responses.Exploratory objectives for the study include examining the
relationship between tumor expression of Facilitates Chromatin Transcription
(FACT), the molecular target of CBL0137, tumor response and the effect of
CBL0137 on FACT expression in peripheral blood mononuclear cells and on
soluble factors in serum.
A Phase 1, single agent, dose escalation study of oral administration of
CBL0137 in patients with advanced solid tumors that are resistant or
refractory to standard of care treatment is ongoing in the Russian Federation.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer of CBLI, commented, "We are
pleased to announce the opening of an IND for CBL0137 in the U.S.Our recently
expanded knowledge regarding FACT expression in tumors and the potential
ability to obtain additional data on CBL0137's impact on FACT expression
through initial trials in US and Russia will be invaluable as we plot the
future clinical development of CBL0137."
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging
deep mechanistic understanding of the cell death process, apoptosis, to
develop a robust pipeline of compounds primarily focused on oncology
applications and mitigation of radiation injury. The Company's lead compound
is being developed as both a radiation countermeasure and a cancer treatment.
The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs,
Inc., and strategic relationships with the Cleveland Clinic, Roswell Park
Cancer Institute, the Children's Cancer Institute Australia 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.
About Incuron, LLC
Incuron, LLC is a Russian Federation based joint venture founded in 2010
between Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures," and
Cleveland BioLabs. Incuron is developing CBL0102 and CBL0137 for oncology and
orphan indications. To learn more about Incuron, LLC, please visit the
company's website at http://www.incuron.com/.
This press release contains certain forward-looking information about
Cleveland BioLabs that is intended to be covered by the safe harbor for
"forward-looking statements" provided by the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements are statements that
are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s),"
"will," "may," "anticipate(s)" and similar expressions are intended to
identify forward-looking statements. These statements include, but are not
limited to, statements regarding our ability to successfully obtain regulatory
approval for our therapeutic product candidates; statements regarding our
ability to successfully develop and commercialize our therapeutic products;
our ability to expand our long-term business opportunities; the conduct and
results of our various clinical trials; and future performance. All of such
statements are subject to certain risks and uncertainties, many of which are
difficult to predict and generally beyond the control of the Company, that
could cause actual results to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These factors include, among others, the Company's inability to obtain
regulatory approval in a timely manner or at all; the Company's failure to
develop new products; the Company's collaborative relationships and the
financial risks related thereto; the risks inherent in the early stages of
drug development and in conducting clinical trials. Some of these factors
could cause future results to materially differ from the recent results or
those projected in forward-looking statements.See also the "Risk Factors" and
"Forward-Looking Statements" described in the Company's periodic filings with
the Securities and Exchange Commission.
Rachel Levine, Vice President, Investor Relations
Cleveland BioLabs, Inc.
T: (646) 284-9439
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