BUFFALO, NY -- (Marketwire) -- 12/22/09 -- Cleveland BioLabs, Inc. (
"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.
Contact:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com