SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

March 16, 2015 07:30 ET

Cleveland BioLabs Announces Completion of Dosing in Phase 1 Study of CBLB612 in Russian Federation

BUFFALO, NY--(Marketwired - Mar 16, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that a maximally tolerated dose has been reached and that dosing has been completed in a Phase 1 healthy subject study of CBLB612, an investigational drug in development for mobilization of hematopoietic stem cells (HSCs) and for the prevention of chemotherapy-induced myelosuppression.

The objectives of the study include establishing a maximally tolerated dose, evaluating the safety profile and pharmacokinetics of CBLB612, and characterizing the type, quantity and timing of HSC mobilization. Analysis of data from the 56 healthy volunteers enrolled in the study is ongoing and data are expected to be reported in the second quarter of 2015. This study is partially funded through a contract from the Ministry of Industry and Trade of the Russian Federation.

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as a potential cancer treatment. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and through two joint ventures, Panacela Labs, Inc. and Incuron, LLC. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.

This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words and phrases such as "expected," "ongoing" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the conduct and results of our various clinical trials; the efficacy of our therapeutic products; our ability to successfully complete planned clinical studies; and our ability to obtain regulatory approval for our therapeutic products. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

These factors include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; subsequent changes in the agreement with the Russian Ministry of Industry and Trade; and the Company's inability to obtain regulatory approval in a timely manner or at all. 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 Information

  • Contacts:
    Cleveland BioLabs, Inc.
    Rachel Levine
    Vice President, Investor Relations
    T: 917-375-2935
    E: rlevine@cbiolabs.com