BUFFALO, NY--(Marketwire - October 19, 2011) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that a new Investigational New Drug (IND) application for clinical testing of CBLB502 in a variety of oncologic patient settings has been opened with the U.S. Food and Drug Administration (FDA). The Company also announced that the Investigational Review Board (IRB) at Roswell Park Cancer Institute has approved a protocol for the first trial of CBLB502 in advanced cancer patients. Alex Adjei, M.D., Ph.D., FACP, Chairman of the Department of Medicine and Senior Vice President of Clinical Research at Roswell Park Cancer Institute, an internationally recognized expert in clinical drug development who has pioneered a large number of Phase I trials with oncology drugs, will lead the trial as Principal Investigator.
This trial is based on results from preclinical studies indicating that CBLB502, a drug under development to reduce the risk of death following exposure to radiation, has anticancer properties when administered as a single agent in a number of experimental tumor models (colon and lung cancer, lymphoma and melanoma) in animals, particularly in tumors localized in the liver. The study will evaluate the safety and pharmacokinetic profile of CBLB502 in patients with advanced cancers. Up to forty-eight patients are expected to be enrolled in multiple trial cohorts to determine the safety, tolerability, and maximum tolerated dose (MTD) of repeated administrations of CBLB502. Evaluations for any preliminary evidence of anticancer activity of CBLB502 in advanced cancer patients will also be performed.
Andrei Gudkov, Ph.D., D.Sc., Chief Scientific Officer of Cleveland BioLabs, and Senior Vice President of Basic Science at Roswell Park Cancer Institute, commented, "This is a landmark event in our clinical program that reflects a significant advancement in exploring the unique therapeutic potential of CBLB502. Success in this direction of CBLB502's development will be an indication that this agent uniquely combines properties of both supportive care and anticancer drugs. I am unaware of any precedent of this kind among drugs currently used in oncology."
Michael Kurman, MD, Chief Medical Officer of Cleveland BioLabs, stated, "The trial we are announcing today should give us information that would allow us to optimize future trial protocols, particularly with respect to the effects of CBLB502 when applied in a multiple dose regimen, and expedite initiation of additional trials with CBLB502 aimed at evaluation of potential radioprotective effects in oncologic supportive care settings."
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 relationships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about ClevelandBioLabs, Inc., please visit the company's website at 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.
These factors include, among others, the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts; the Company's failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company's ability to comply with various safety, environmental and other governmental regulations. 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.