Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs President and CEO Reports Progress on Clinical and Corporate Developments
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - December 22, 2009) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
issued a statement from its President and CEO, Michael Fonstein, Ph.D.,
providing an update on clinical and corporate developments of the past
year. The statement is included in its entirety below:
"As we close 2009, I would like to take this opportunity to reflect upon
some of our accomplishments and update you on our overall progress. We have
made great strides in the development of our most advanced compound,
CBLB502 for Acute Radiation Syndrome (ARS), secured significant additional
government funding, received our first US patent, and advanced commercial
partnerships for two of our programs.
CBLB502
As we have reported previously, CBLB502 is being developed under the U.S.
Food and Drug Administration's (FDA) Animal Efficacy Rule to treat ARS and
this approval pathway requires demonstration of efficacy in representative
animal models and safety and drug metabolism testing in healthy human
volunteers.
Earlier this year, we were pleased to conclude our first human safety and
tolerability study with CBLB502, in which data from 50 subjects indicated
that CBLB502 was well tolerated and that normalized biomarker results
corresponded to previously demonstrated activity in animal models of ARS.
Our original strategy for clinical development of CBLB502 for ARS, as
outlined last year and in early 2009, was to progress directly from the
initial safety study to a definitive double-blind safety study in a larger
group of healthy volunteers. Since then, certain developments related to
the potential commercialization of CBLB502 and other observations from the
initial safety and tolerability trial have resulted in a modification of
this strategy to include an intermediary 100 subject trial, which we
recently announced.
The primary objectives of the 100 subject study, outside of commercial
goals, are to gather additional data on safety, pharmacokinetics, and
cytokine biomarkers in a larger and broader subject population in order to
finalize a single dose to take forward and determine the size of the
definitive human volunteer study. As announced, screening of volunteers for
this trial has commenced and we expect to begin dosing subjects in January.
Our goal is for dosing and data analysis of this trial to be concluded in
the spring of 2010. We would then anticipate moving forward with the
double-blind definitive safety study in a larger group of healthy
volunteers. We believe the addition of the intermediate 100 subject trial
will be very beneficial for both the potential commercialization of CBLB502
and our regulatory process towards FDA licensure.
As we move forward with development, we are also eagerly anticipating the
next step in the Department of Defense's (DoD) process of identifying
sources that have the capability to develop, through FDA approval and
production, a radiological/nuclear therapeutic medical countermeasure. The
Sources Sought Notice published by the DoD last May described such a
countermeasure as one that would be administered following exposure to
ionizing radiation that will decrease incapacity and prolong survival by
treating the gastrointestinal sub-syndrome of ARS. We believe CBLB502 fits
these criteria.
Turning to medical applications for CBLB502, we are excited about the
pending start of our first Phase I/II clinical trial in head and neck
cancer patients who are undergoing radiotherapy and radio-sensitizing
chemotherapy. The primary goal of this trial will be to demonstrate safety
and tolerability of CBLB502 in cancer patients with a secondary goal of
demonstrating potential efficacy of CBLB502 in a clinical setting through
reduction of occurrence and severity of certain common and debilitating
side effects of cancer therapy, such as mucositis. We are finalizing
preparations and anticipate starting dosing in the first quarter of 2010.
CBLB612
In September, we announced a licensing agreement for CBLB612, a drug in
development for stimulation of hematopoietic stem cell proliferation and
mobilization to peripheral blood, with Zhejiang Hisun Pharmaceutical Co., a
leading pharmaceutical manufacturer in the People's Republic of China. The
agreement grants Hisun exclusive rights to develop and commercialize
CBLB612 in the People's Republic of China and brings $1.65 million in
upfront product development payments, as well as a 10% royalty on any net
sales.
We are very excited about the commercial validation provided by this
license agreement, especially given CBLB612's preclinical development
status, and look forward to seeing the pre-clinical and clinical data
generated by Hisun for Chinese State Food and Drug Administration approval.
Curaxins
Earlier in 2009, we signed a term sheet with Bioprocess Capital Ventures, a
Russian venture capital fund, to enter into a joint venture to develop our
Curaxin compounds for cancer applications. The proposed terms contemplate a
50% split of the joint venture, with us transferring rights to our pipeline
of Curaxin anticancer molecules to the new joint venture, and Bioprocess
Capital Ventures contributing approximately $15 million over three years to
support development of the compounds. Although not yet finalized, the
parties are diligently working towards definitive agreements reflecting
this relationship.
Corporate
Significant corporate developments include the receipt of a Notice of
Allowance from the U.S. Patent and Trademark Office for our first major
patent for CBLB502 in September. Allowed claims cover the method of
protecting a mammal from radiation using flagellin or its derivatives,
including CBLB502. A similar patent was granted by the nine member
countries of the Eurasian Patent Organization (EAPO) and two additional
countries.
September and October also saw a multitude of announcements regarding
additional government grants and contract extensions totaling almost $9
million over the next 12-24 months, bringing total government funding
received for CBLB502 in 2008/2009 to more than $32 million. CBLB502
programs received repeat funding from the Department of Defense, the
Biomedical Advanced Research and Development Authority of the Department of
Health and Human Services, and the National Institute of Allergy and
Infectious Diseases of the National Institutes of Health. Of particular
note was the new award by the National Institutes of Health of a highly
competitive $5.3 million Grand Opportunities grant under the American
Recovery and Reinvestment Act of 2009.
We look forward to sharing our progress on all of these fronts with you and
appreciate your support."
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company
leveraging its proprietary discoveries around programmed cell death to
develop treatments for cancer and protection of 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 30, 2009.