BUFFALO, NY--(Marketwired - Sep 15, 2014) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced approval from the Ministry of Health of the Russian Federation to start a Phase 1 clinical trial with CBLB612, a drug in development for the induction and mobilization of hematopoietic stem cells (HSC).
The study will be conducted in healthy subjects and is planned to start in the fourth quarter of 2014. 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. This study is partially funded through a contract from the Ministry of Industry and Trade of the Russian Federation.
CBLB612's demonstrated preclinical activity as an inducer and mobilizer of HSC makes it a candidate for potential use to enhance collection of HSC for use in transplantation. HSC are commonly mobilized into the circulating peripheral blood and then collected from the donor through leukapheresis. Injections of mobilizing drugs are commonly used to increase HSC yield in this process.
Studies in mice and non-human primates have shown that a single administration of CBLB612 induces a greater concentration of HSC in peripheral blood in experimental animals than currently available mobilizing drugs. These studies have also revealed a potent synergistic effect on the mobilization of HSC in these species when CBLB612 is combined with these current standard-of-care agents. An improved mobilizing regimen could increase the numbers of mobilized HSC, potentially minimizing the need for leukapheresis from the donor and enhancing bone marrow recovery in the recipient.
About Cleveland BioLabs
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 lead product candidates are entolimod, which is being developed for a biodefense indication and as a potential cancer treatment, and Curaxin CBL0137, our lead oncology product candidate. The company conducts business in the United States and in the Russian Federation through our three operating subsidiaries, Incuron, LLC, BioLabs 612, LLC and Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, and the Children's Cancer Institute Australia. 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 such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "planned," "potential" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to obtain approval from the Ministry of Health of the Russian Federation for CBLB612; our ability to conduct Phase 1 clinical trials of CBLB612 and meet the objectives of such study; CBLB612's ability to mobilize and enhance collection of HSC; our ability to successfully develop and commercialize our therapeutic products, including CBLB612; and future performance. 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 risks and uncertainties include, among others, the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's failure to successfully complete Phase 1 clinical trials of CBLB612 or to demonstrate the safety or efficacy of CBLB612; the Company's failure to successfully and timely develop existing and new products, including CBLB612; the Company's collaborative relationships and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's ability to comply with its obligations under license agreements; 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. 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.