Cleveland BioLabs Completes Recruitment For Phase II Hormone-Refractory Prostate Cancer Trial

Main Category: Prostate / Prostate Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 08 May 2008 - 3:00 PDT

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Cleveland BioLabs, Inc. (NASDAQ: CBLI), announced that it has fully enrolled its Phase II clinical trial of Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer.

This open label trial is evaluating the safety and efficacy of Curaxin CBLC102 for use in treating patients with hormone-refractory metastatic prostate cancer. Curaxins have multiple mechanisms of action, including simultaneous activation of p53 and inhibition of NF-kappaB, which are frequently deregulated in cancer. Compounds that target p53 or NF-kappaB independently have been validated as cancer therapies; however, Curaxins are the only compounds currently known to CBLI that simultaneously target both pathways.

The planned enrollment of 32 patients from four medical centers in the United States was completed on April 29, 2008. Patients were evaluated prior to treatment with Curaxin CBLC102 and at one-month intervals for a maximum of six months. The goals of the trial were to confirm the safety and tolerability of CBLC102 in patients with hormone-refractory metastatic prostate cancer and to evaluate the efficacy of CBLC102 in this patient population through assessments of PSA levels, reductions in tumor size and disease free survival periods. The results of this trial are anticipated to be available in the fourth quarter of 2008.

Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein, Ph.D., commented, "Curaxin 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. We are hopeful that this trial will provide preliminary evidence that this therapeutic approach may benefit patients with advanced prostate cancer."

About 30,000 men die of 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, hormone-refractory metastatic prostate cancer remains essentially incurable. The FDA has assigned orphan-drug status to treatments for hormone-refractory prostate cancer, which rewards developers with tax reductions and marketing exclusivity on approved drugs for an extended time period.

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 Radiobiology Research 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. The Company's 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 the Company's periodic filings with the Securities and Exchange Commission.

Cleveland BioLabs, Inc.