BUFFALO, N.Y., Aug. 7, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq: CBLI ) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that a multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas is open for enrollment and that treatment of the first patient has been initiated.
The primary objective of the study is to determine the maximally tolerated dose and recommend a Phase 2 dose for CBL0137 in these patients. Secondary objectives include describing the dose limiting toxicity, adverse event and pharmacokinetic profile of CBL0137, as well as documenting any objective responses. Exploratory objectives for the study include examining the relationship between tumor expression of Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137, tumor response and the effect of CBL0137 on FACT expression in peripheral blood mononuclear cells and on soluble factors in serum. FACT expression will also be tested on patient's tumor tissue retrospectively to determine if the tumor signal can help guide patient selection for future studies.
The Company recently announced the publication of studies describing FACT as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports. The published work concluded that FACT's role in cancer likely involves selective chromatin remodeling of genes that stimulate proliferation, inhibit cell death and differentiation, and regulate cellular stress responses, making it an enabler of oncogene-induced transformation. Further studies are underway to determine if this biomarker can serve as a companion diagnostic to screen patients for CBL0137 treatment.
Jean Viallet, M.D., Chief Development Officer at Cleveland BioLabs, commented, "We are excited to have a second study with CBL0137 underway. The role of FACT as an enhancer of oncogenic transcription supports the clinical potential for CBL0137."
Additional information about the trial may be found at: www.clinicaltrials.gov .
A Phase 1, single agent, dose escalation study of oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment is ongoing in the Russian Federation.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia 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 .
About Incuron, LLC
Incuron, LLC is a Russian Federation based joint venture founded in 2010 between Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures," and Cleveland BioLabs. Incuron is developing CBL0102 and CBL0137 for oncology and orphan indications. To learn more about Incuron, LLC, please visit the company's website at http://www.incuron.com/ .
This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully obtain regulatory approval for our therapeutic product candidates; statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; the conduct and results of our various clinical trials; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These factors include, among others, the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's failure to develop new products; the Company's collaborative relationships and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.
Contact:
Rachel Levine, Vice President, Investor Relations
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com
