Statera BioPharma

Cleveland BioLabs, Inc. (Nasdaq:CBLI)] is a biotechnology company leveraging its proprietary discoveries around programmed cell death (apoptosis) to develop a pipeline of drugs for multiple medical and defense applications.

The Company was founded in partnership with the Cleveland Clinic in 2003. The Cleveland Clinic retains a board seat and significant shareholding in the company. The company has also a strategic alliance with Roswell Park Cancer Institute, in Buffalo, NY, where the company is currently headquartered. Other strategic alliances or partnerships include ChemBridge Corporation and the Armed Forces Radiobiology Research Institute.

Products

The company's pipeline includes products from two primary families of compounds: Protectans and Curaxins. Protectans are being developed as drug candidates that protect normal tissues from acute stresses such as radiation, chemotherapy and ischemias (pathologies developed as a result of blocking blood flow to a part of the body). Curaxins are being developed as anticancer agents that could act as monotherapy drugs or in combination with other existing anticancer agents.

Is most advanced product candidate is Protectan CBLB502, a microbial protein derivative, which has demonstrated the capacity to reduce injury from acute stresses, such as radiation and chemotherapy, in animal models. It mobilizes several cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

It is in active development under the U.S. Food and Drug Administration’s (FDA) Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon or dirty bomb, or from a nuclear accident. This pathway requires demonstration of efficacy in representative animal models and safety and drug metabolism testing in healthy human volunteers.

Evidence of its mechanism of action and activity in animal models was published in Science Magazine in April 2008.^[1] Data from 50 subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. This will be followed by a second, larger safety study in healthy human volunteers. There is currently no FDA approved medical countermeasure to treat ARS.

The substance is also being developed as a supportive care measure to reduce and prevent occurrence of side effects of radiotherapy or chemotherapy in cancer treatment.

Another compound in the Protectan family, CBLB612, is a modified lipopeptide of mycoplasma, which has demonstrated the ability to induce hematopoietic stem cells in bone marrow and mobilize them into peripheral blood in animal studies. Potential applications include accelerated hematopoietic recovery during chemotherapy, and during donor preparation for bone marrow transplantation.

The company's Curaxin family of anticancer compounds includes CBLC102 an aminoacridine, and CBLC137, a Carbazole. CBLC102 demonstrated safety and activity in a Phase II trial in hormone-refractory prostate cancer, which was concluded in 2008. Insights into the mechanism of action of CBLC102 were published in Oncogene in January 2009.^[2]

Senior management

Cleveland BioLabs was founded by Michael Fonstein, Andrei Gudkov, and Yakov Kogan.

Fonstein is Chief Executive Officer and President. He served as Director of the DNA Sequencing Center at the University of Chicago from its creation in 1994 to 1998, when he left to found Integrated Genomics, Inc. located in Chicago, Illinois. He served as CEO and President of Integrated Genomics from 1997 to 2003.He has won several awards, including the Incubator of the Year Award from the Association of University Related Research Parks and a KPMG Illinois High Tech Award.

Gudkov is Chief Scientific Officer. Prior to 1990, he led a broad research program on virology and cancer drug resistance at The National Cancer Research Center in Moscow (USSR). In 1990, he moved to the University of Illinois at Chicago where he became a tenured faculty member in the Department of Molecular Genetics. His lab concentrated on the development of new functional gene discovery methodologies and the identification of candidate cancer treatment targets. In 1999, he defined p53 as a major determinant of cancer treatment side effects and suggested this protein as a target for therapeutic suppression. In 2001, he moved to the Lerner Research Institute at the Cleveland Clinic as Chairman of the Department of Molecular Biology and Professor of Biochemistry at Case Western Reserve University. In 2007, he accepted the position of Senior VP Basic Science and Chair, Department of Cell Stress Biology at Roswell Park Cancer Institute in Buffalo, NY. Gudkov divides time between work for CBLI and for Roswell Park.

Kogan is Chief Operating Officer. From 2001 to 2003, he was Director for Business Development at Integrated Genomics,Previously, he worked as a Group Leader/Senior Scientist at Integrated Genomics and ThermoGen, Inc. and as Research Associate at the University of Chicago. He holds a Ph.D. degree in Molecular Biology from VNII Genetica, as well as an M.S. degree in Biology from Moscow State University and an MBA from the University of Chicago.

References

External links

Company home page

[1] Science, 2008, vol. 320, pp. 226-230

[2] Guo et al., Oncogene, 2009, 28:1151-1161

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