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Cleveland BioLabs announces Russian contract agreement
BUFFALO, N.Y.—Cleveland BioLabs, Inc. has announced the signing of a contract with a value of 139 million rubles (approximately $4 million) through its wholly owned Russian subsidiary. The contract was established with the Ministry of Industry and Trade of the Russian Federation for the development of Cleveland BioLabs' CBLB612, a drug currently being developed to stimulate hematopoietic stem cell proliferation and mobilization. Per the terms of the agreement, the contract will provide funding over roughly three years to support completion of preclinical studies, the filing of an investigational new drug application and Phase I and II clinical studies for the drug.
CBLB612 has shown proven activity in terms of inducing hematopoietic stem cells to proliferate and mobilize, and as such, one of its most promising applications could be in the use of bone marrow transplantation. In mice and non-human primate studies, a single administration of the drug was demonstrated to induce a greater concentration of hematopoietic stem cells in peripheral blood in the experimental animals than the current standard therapy. In addition, the studies also showed that CBLB612 has a significant synergistic effect on the proliferation and mobilization of the stem cells when it is administered alongside current standard treatments.
"We are pleased to have received this substantial non-dilutive funding, a key component of our financing strategy," Yakov Kogan, Ph.D., CEO of Cleveland BioLabs, said in a press release. "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."
Approximately 30,000 people in the United States have bone marrow transplants each year, potentially qualifying transplant drug candidates for orphan drug status with the U.S. Food and Drug Administration. Patients receiving bone marrow transplants require hematopoietic stem cells in order to get a clinical benefit from the treatment, and one of the challenges of the procedure for some patients is to enrich large enough quantities of the cells to ensure a successful outcome.
Cleveland BioLabs has also announced that patents have been issued or allowed in Mexico, Japan and China to cover methods that use CBLB612 and related compounds to protect against apoptosis. This patent has been issued or allowed in other countries as well, including the United States, Eurasia (including the Russian Federation and eight other countries), Australia, South Africa and New Zealand. In addition, a CBLB612 patent has also been granted in South Africa that covers methods for increasing and mobilizing hematopoietic stem cells.
The contract falls under Russia's Pharma 2020 initiative, which began in 2007, and seeks to rebuild Russia's pharmaceutical industry. The project aims at increasing domestic drug development in Russia by bolstering the country's ability to take drugs from the discovery phase all the way through manufacturing. Pharma 2020 will focus on all aspects of the goal, from increasing the provision of domestically produced medicines, to "technical re-equipment of the Russian pharmaceutical industry," to adjusting its educational system to create new programs and avenues for the next generation of pharmaceutical specialists.
SOURCE: Cleveland BioLabs, Inc. press release