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Cleveland BioLabs announces Russian contract agreement
07-31-2012
SHARING OPTIONS:
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 Code: E07311201 Back |
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