BUFFALO, N.Y., July 30, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that, through a wholly-owned Russian subsidiary, it has signed a contract valued at 139 million rubles, or approximately $4 million (based on current exchange rates), with the Ministry of Industry and Trade of the Russian Federation for development of CBLB612, a drug in development for stimulation of hematopoietic stem cell proliferation and mobilization. The contract, issued under Russia's "Pharma 2020" development initiative, provides funding over a period of approximately three years, which will be used to support completion of preclinical studies, filing of an IND and Phase I and II clinical studies.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer, commented: "We are pleased to have received this substantial non-dilutive funding, a key component of our financing strategy. This contract enables us to continue our work with CBLB612. We believe that our success in securing this type of highly competitive funding is driven by the strength of our science and development capabilities."
CBLB612's demonstrated activity as an inducer of hematopoietic stem cell proliferation and mobilization makes it a candidate for potential use in applications such as bone marrow transplantation. Studies in mice and non-human primates have shown that a single administration of CBLB612 induces a greater concentration of hematopoietic stem cells in peripheral blood in experimental animals than the current standard course of therapy. These studies have also revealed a potent synergistic effect on the proliferation and mobilization of hematopoietic stem cells in these species when combined with current standard care agents.
Bone marrow transplants are performed on approximately 30,000 patients in the United States each year, which potentially qualifies drug candidates targeting this indication for orphan drug status with the United States Food and Drug Administration. Bone marrow transplant patients require enrichment of hematopoietic stem cells to derive a clinical benefit from the treatment. One of the challenges of bone marrow transplant for some patients is enriching these cells in large enough numbers to have a successful outcome.
The Company also announced that patent authorities in Mexico, Japan and China have issued or allowed patents covering methods of protecting against apoptosis using CBLB612 and related agents. This patent has already been issued or allowed in other territories including the United States, Australia, Eurasia (including the Russian Federation and eight other countries), New Zealand and South Africa. Another CBLB612 patent covering methods of increasing and mobilizing hematopoietic stem cells has been granted in South Africa.
More information about the Pharma 2020 program may be found at: http://www.pharma2020.ru/
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 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 cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia 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.
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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.
Rachel Levine, Director Investor Relations & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439