BUFFALO, NY -- (MARKET WIRE) -- 02/07/08 -- Cleveland BioLabs, Inc. (
Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, will give a presentation on the Company's lead compounds and development strategy on February 12, at 3:30 p.m. ET. The presentation will be broadcast live over the Internet. Interested parties may tune in to the live presentation by visiting the Investor Information section of the Company's website at: www.cbiolabs.com.
"We continue to develop our lead compounds for both medical and defense applications, while we are in the midst of the Department of Defense debriefing process. We are also pursuing opportunities to work with the U.S. and other governments on various radiation protection initiatives," stated Dr. Fonstein.
Cleveland BioLabs' pipeline includes products from two primary families of compounds: Protectans are being developed as drug candidates that protect healthy tissues from acute stresses such as radiation, chemotherapy and ischemia (conditions in which blood flow, and thus oxygen, is restricted to a part of the body). Curaxins are being developed as anticancer agents that could act as mono-therapy drugs or in combination with other existing anticancer agents.
One of the Company's lead compounds, Protectan CBLB502, is a modified microbial protein that temporarily protects cells from regulated cell death and enables them to repair damage acquired through acute stresses. Potential applications for CBLB502 are broad and include reduction of radiation therapy or chemotherapy side effects in cancer patients, protection from Acute Radiation Syndrome (ARS) in defense scenarios, and protection from acute organ failure.
Protectan CBLB502 is the first compound of its kind to provide protection from both gastrointestinal and hematopoietic (bone marrow/blood production) radiation-induced damage. The Company intends to initiate a Phase I human safety study in the first half of 2008 for CBLB502 in ARS, which is the final stage of human testing required for approval in this indication. At the same time, Cleveland BioLabs plans to initiate a Phase I/II study for CBLB502 in head and neck cancer patients for reduction of side effects of radiation and chemotherapy, such as mucositis, which is a treatment-limiting factor.
Protectan CBLB612 is a modified lipopeptide mycoplasma that acts as a powerful stimulator and mobilizer of hematopoietic stem cells (HSC) to peripheral blood. Potential applications for CBLB612 include accelerated hematopoietic recovery during chemotherapy, as well as during donor preparation for bone marrow transplantation. With efficacy and non-GLP safety already studied in mice and monkeys, CBLB612 will enter formal pre-clinical safety and manufacturing development in February 2008. Its first human trials are projected for early 2009.
Direct comparisons of Protectan CBLB612 and the market leading drug for propagation and mobilization of HSC to peripheral blood, G-CSF, injected as single agents or in combination with AMD3100, demonstrated much stronger efficacy of CBLB612 as a stimulator and mobilizer of HSC in peripheral blood.
Cleveland BioLabs has ongoing collaborations with the Armed Forces Radiobiology Research Institute (AFRRI) and the Defense Threat Reduction Agency of the Department of Defense for the development of both Protectan CBLB502 and Protectan CBLB612.
The most advanced product candidate in the Curaxin family is CBLC102, an orally administered small molecule designed to kill tumor cells. The Company has an ongoing Phase II trial with CBLC102 in hormone refractory prostate cancer and expects to report the results of this trial in the fist half of 2008. CBLC102, discovered in an anti-cancer screening assay is an old, discontinued drug, quinacrine, formerly used against malaria. Its further development will include testing against other cancers, as well as clarifying its potential use in prostate cancer through further dose escalation studies.
An entirely proprietary next generation of Curaxins has been created through extensive hit-to-lead optimization, which has provided potentially improved efficacy and a broader therapeutic window. Since these are new molecular entities, they are patentable as composition-of-matter. These new Curaxins are entering formal pre-clinical safety and manufacturing development. Their first human trials are projected for early 2009.
"We have an exciting and robust pipeline of compounds based on our unique approach to drug discovery," concluded Dr. Fonstein. "We look forward to sharing our progress and milestones as we create value for all of our stakeholders."
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.
Contacts:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com