Cleveland BioLabs launches Phase II advanced renal cell carcinoma trial for Curaxin CBLC102

Abstract

Cleveland BioLabs, Inc. (NASDAQ:CBLI), today announced the initiation of its Phase II efficacy study for Curaxin CBLC102 in advanced renal cell carcinoma (a highly fatal form of kidney cancer) at ClinWorks Cancer Research Center in Charlotte, NC.

Curaxin CBLC102 is a safe, oral drug that was used to treat malaria during World War II. In addition to its anti-malaria effects, laboratory results have shown that it is effective against several malignancies, including renal cell carcinoma. 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, "The aim of this study is to confirm CBLC102's potential efficacy for this difficult to treat and often fatal condition. We are pursuing multiple Phase II trials for Curaxin CBLC102 in order to determine the most responsive cancer targets for its mechanism of action and establish optimal dosing regimens.

CBLC102 is the most advanced compound in our anticancer pipeline and as a previously commercialized drug, it represents an accelerated pathway for development. Moreover, we have exploited our understanding of the mechanism of action of CBLC102 to develop a pipeline of proprietary, anticancer drug candidates."

Renal cell carcinoma is the sixth leading cause of cancer death. More than 36,000 new cases of renal cell carcinoma were diagnosed in 2005, and more than 12,000 of these cases resulted in death. Five-year survival rates initially reported in 1969 were 66% for stage I renal carcinoma, 64% for stage II, 42% for stage III, and only 11% for stage IV. Except for stage I, these survival statistics have remained essentially unchanged for several decades.

Renal cell carcinoma is resistant to both radiation and chemotherapy. There is evidence of infrequent, but reproducible response to immunotherapy agents (interferon alpha and interleukin (IL)-2), and new antiangiogenesis agents (sorafenib and sunitinib). The overall response to these therapies, however, is not curative, and treatment-associated toxicities may be severe.

The Phase II study will enroll up to 24 subjects at 4-6 sites in the US with advanced (stage IV) renal cell carcinoma. The primary endpoint for the study is decrease in tumor size. Secondary endpoints include time to tumor progression. The duration of the study is expected to be two years.

The Company intends to initiate an additional Phase II study of Curaxin CBLC102 in multiple cancer types in early 2008.

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, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute. To learn more about Cleveland BioLabs Inc., please visit the company's website at http://www.cbiolabs.com.