Cleveland, Dec. 4 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. (NASDAQ:CBLI)(BSE:CFB), announced today the initiation of its Phase II efficacy study for Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer at the Cleveland Clinic and Case Western Reserve University Hospital.

Curaxin CBLC102 is a safe, oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models, and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal cell carcinoma (a highly fatal form of kidney cancer), and soft-tissue sarcoma. The FDA permitted Cleveland BioLabs to advance directly to Phase II studies, based on CBLC102's historic safety profile. The Company has a "method of use" patent application pending on Curaxin CBLC102.

Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein, Ph.D., commented, "We are pleased to have this study underway, as the results will further validate our therapeutic strategy for treating cancer. CBLC102 is the most advanced compound in our anti-cancer pipeline and presents a significant and unique market opportunity as a potential oral therapy for cancer. Its status as a previously approved and historically used therapy for malaria establishes an accelerated pathway for development due to its proven safety profile. In addition, we have exploited our discoveries regarding the mechanisms utilized by cancer for survival to isolate and develop several additional, proprietary anti-cancer drug candidates with the same mechanism of action."

About 30,000 men die of androgen-independent (hormone-refractory) metastatic prostate cancer each year in the U.S. Taxanes (a group of chemotherapy drugs that kill cancer cells by stopping their growth) are the most effective chemotherapeutic approach to treating advanced prostate cancer. Some recent studies have yielded modest improvements in survival rates; however, androgen-independent metastatic prostate cancer remains essentially incurable. The FDA has assigned orphan-drug status to treatments for androgen-independent prostate cancer, which rewards developers with tax reductions and marketing exclusivity on approved drugs for an extended time period.

The Phase II study will involve 31 patients with advanced, refractory prostate cancer. The dosing regimen includes a 300 mg loading dose three times daily for seven days, followed by a 100 mg maintenance dose administered once daily for an additional 23 weeks. Primary endpoints for the study are reduction in PSA levels, reduction in tumor size, and disease-free survival. The duration of the study is two years, however certain preliminary data may be available earlier.

CBLC102 has a unique mechanism of action, simultaneously hitting two key cancer targets: p53 and NF-kB (nuclear factor kappa B); which research indicates would be effective in the majority of cancers. This mechanism of action was identified through research conducted by scientists at Cleveland BioLabs and the Cleveland Clinic Foundation, which was published in the November 14, 2005 issue of the Proceedings of the National Academy of Sciences (PNAS).

In this publication, the research team describes a novel mechanism of p53 inactivation that is employed by many cancers, including renal cell carcinoma (RCC). RCC commonly retains wild-type, but functionally inactive p53, which is repressed by an unknown dominant mechanism. This mechanism is mediated through deregulation of another important cancer treatment target, naturally involved in inflammatory response, named NF-kB. This discovery not only provided a new link between inflammation and cancer, but also enabled the formulation of a new therapeutic strategy of simultaneous targeting two major cancer-related pathways with a single drug. Moreover, the researchers validated this approach by isolating small molecules capable of selective killing of tumor cells through this bi-targeting mechanism. These isolated molecules block NF-kB in a way that is different from other inhibitors that are currently in different stages of clinical development.

The Company plans to start a Phase II study of CBLC102 in renal cell carcinoma in 2007.

    The PNAS article may be accessed at:

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic Foundation, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute. To learn more about Cleveland BioLabs Inc., please visit the company's website at

This press release contains forward-looking statements that reflect our current view with respect to various aspects of the events described above. Actual results could be significantly different. Factors that could affect results include those set forth in filings made by Cleveland BioLabs, Inc. with the Securities and Exchange Commission. These factors include, but are not limited to, those discussed in our Registration Statement on Form SB-2 under the caption "Risk Factors."

     The Global Consulting Group
     Rachel Levine
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