Contact Information: Contacts: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@hfgcg.com
Cleveland BioLabs Launches Phase II Advanced Renal Cell Carcinoma Trial for Curaxin CBLC102
Oral Compound With Historical Safety Profile; Currently in Phase II Trial for Hormone-Refractory Prostate Cancer
| Quelle: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - November 26, 2007) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced the initiation of its Phase II efficacy study for Curaxin CBLC102
in advanced renal cell carcinoma (a highly fatal form of kidney cancer) at
ClinWorks Cancer Research Center in Charlotte, NC.
Curaxin CBLC102 is a safe, oral drug that was used to treat malaria during
World War II. In addition to its anti-malaria effects, laboratory results
have shown that it is effective against several malignancies, including
renal cell carcinoma. The Company has a "method of use" patent application
pending on Curaxin CBLC102.
Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein,
Ph.D., commented, "The aim of this study is to confirm CBLC102's potential
efficacy for this difficult to treat and often fatal condition. We are
pursuing multiple Phase II trials for Curaxin CBLC102 in order to determine
the most responsive cancer targets for its mechanism of action and
establish optimal dosing regimens. CBLC102 is the most advanced compound
in our anticancer pipeline and as a previously commercialized drug, it
represents an accelerated pathway for development. Moreover, we have
exploited our understanding of the mechanism of action of CBLC102 to
develop a pipeline of proprietary, anticancer drug candidates."
Renal cell carcinoma is the sixth leading cause of cancer death. More than
36,000 new cases of renal cell carcinoma were diagnosed in 2005, and more
than 12,000 of these cases resulted in death. Five-year survival rates
initially reported in 1969 were 66% for stage I renal carcinoma, 64% for
stage II, 42% for stage III, and only 11% for stage IV. Except for stage
I, these survival statistics have remained essentially unchanged for
several decades.
Renal cell carcinoma is resistant to both radiation and chemotherapy.
There is evidence of infrequent, but reproducible response to immunotherapy
agents (interferon alpha and interleukin (IL)-2), and new antiangiogenesis
agents (sorafenib and sunitinib). The overall response to these therapies,
however, is not curative, and treatment-associated toxicities may be
severe.
The Phase II study will enroll up to 24 subjects at 4-6 sites in the US
with advanced (stage IV) renal cell carcinoma. The primary endpoint for
the study is decrease in tumor size. Secondary endpoints include time to
tumor progression. The duration of the study is expected to be two years.
The Company intends to initiate an additional Phase II study of Curaxin
CBLC102 in multiple cancer types in early 2008.
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.