Cleveland BioLabs Phase II Hormone-Refractory Prostate Cancer Trial Advances To Next Phase
Cleveland, OH, April 7, 2007. Cleveland BioLabs, Inc. (Nasdaq: CBLI; BSE: CFB), announced today that its Phase II efficacy study for Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer has progressed to the next phase.
Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein, Ph.D., said, "CBLC102's historic safety profile has proven consistent and the hormone-refractory prostate cancer trial is advancing in line with our expectations. CBLC102 is the most advanced compound in our anti-cancer (Curaxin) pipeline and presents a significant and unique market opportunity as a potential oral therapy for cancer."
According to the trial protocol, enrollment of subjects of the Main (Safety/Efficacy) Cohort may be initiated only if a limited number subjects of the First Cohort experience a certain severity of adverse events. This criterion has been achieved, enabling enrollment into the Main Cohort. The first 15 subjects of the Main Cohort will be enrolled and monitored for PSA response throughout their treatment regimen. As soon as PSA response is achieved in at least one subject, the remaining 13 subjects may be enrolled.
The Phase II study will involve a total of 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. The study is being conducted at the University of Chicago, the Cleveland Clinic and the University Hospitals of Cleveland.
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 Company has a "method of use" patent application pending on Curaxin CBLC102.
About 27,000 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 Company plans to start additional Phase II studies of Curaxin CBLC102 in renal cell carcinoma and multiple myeloma in 2007.
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, 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 .
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in our filings with the Securities and Exchange Commission.
Cleveland BioLabs, Inc.
http://www.cbiolabs.com
