Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Completes Recruitment for Phase II Hormone-Refractory Prostate Cancer Trial
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - May 7, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ),
announced today 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.