Cleveland BioLabs announces Russian contract agreement

BUFFALO, N.Y.—Cleveland BioLabs, Inc. has announced thesigning of a contract with a value of 139 million rubles (approximately $4million) through its wholly owned Russian subsidiary. The contract wasestablished with the Ministry of Industry and Trade of the Russian Federationfor the development of Cleveland BioLabs' CBLB612, a drug currently beingdeveloped to stimulate hematopoietic stem cell proliferation and mobilization.Per the terms of the agreement, the contract will provide funding over roughlythree years to support completion of preclinical studies, the filing of aninvestigational new drug application and Phase I and II clinical studies forthe drug.

CBLB612 has shown proven activity in terms of inducinghematopoietic stem cells to proliferate and mobilize, and as such, one of itsmost promising applications could be in the use of bone marrow transplantation.In mice and non-human primate studies, a single administration of the drug wasdemonstrated to induce a greater concentration of hematopoietic stem cells inperipheral blood in the experimental animals than the current standard therapy.In addition, the studies also showed that CBLB612 has a significant synergisticeffect on the proliferation and mobilization of the stem cells when it isadministered alongside current standard treatments.

"We are pleased to have received this substantialnon-dilutive funding, a key component of our financing strategy," Yakov Kogan,Ph.D., CEO of Cleveland BioLabs, said in a press release. "This contractenables us to continue our work with CBLB612. We believe that our success insecuring this type of highly competitive funding is driven by the strength ofour science and development capabilities."

Approximately 30,000 people in the United States have bonemarrow transplants each year, potentially qualifying transplant drug candidatesfor orphan drug status with the U.S. Food and Drug Administration. Patientsreceiving bone marrow transplants require hematopoietic stem cells in order toget a clinical benefit from the treatment, and one of the challenges of theprocedure for some patients is to enrich large enough quantities of the cellsto ensure a successful outcome.

Cleveland BioLabs has also announced that patents have beenissued or allowed in Mexico, Japan and China to cover methods that use CBLB612and related compounds to protect against apoptosis. This patent has been issuedor allowed in other countries as well, including the United States, Eurasia(including the Russian Federation and eight other countries), Australia, SouthAfrica and New Zealand. In addition, a CBLB612 patent has also been granted inSouth Africa that covers methods for increasing and mobilizing hematopoieticstem cells.

The contract falls under Russia's Pharma 2020 initiative,which began in 2007, and seeks to rebuild Russia's pharmaceutical industry. Theproject aims at increasing domestic drug development in Russia by bolsteringthe country's ability to take drugs from the discovery phase all the waythrough manufacturing. Pharma 2020 will focus on all aspects of the goal, fromincreasing the provision of domestically produced medicines, to "technicalre-equipment of the Russian pharmaceutical industry," to adjusting itseducational system to create new programs and avenues for the next generationof pharmaceutical specialists.

SOURCE: Cleveland BioLabs, Inc. press release