BUFFALO, N.Y., March 12, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that the first patient completed an initial series of five doses in a Phase I trial evaluating CBLB502 in advanced cancer patients. 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 cohorts to determine the safety, tolerability, and maximum tolerated dose of repeated administrations of CBLB502. Evaluations for evidence of anticancer activity of CBLB502 in advanced cancer patients will also be performed.
The rationale for the trial is based on preclinical studies indicating that CBLB502, a drug under development to reduce the risk of death following exposure to radiation, may have direct anticancer properties when administered as a single agent in a number of experimental tumor models in animals, particularly in metastatic nodules in the liver.
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, is leading the trial as Principal Investigator.
"We are delighted to begin this first study with CBLB502 in cancer patients," stated Yakov Kogan, Ph.D., MBA, interim Chief Executive Officer of Cleveland BioLabs. "This trial is an important step in the development of a product that we believe has exciting potential in the treatment of cancer."
Additional information about the trial may be found online at:
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 nine 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 direct acting anticancer agent. The Company has two subsidiaries, Incuron, LLC and Pancela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute 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.
The Cleveland BioLabs, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11668
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.
CONTACT: Rachel Levine, Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: firstname.lastname@example.org
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