BUFFALO, NY--(Marketwired - Jan 6, 2015) - Cleveland BioLabs, Inc. (
Dosing of the ninth cohort is underway in a multicenter, phase 1, dose-escalation study assessing the oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to current standard treatment. In parallel, dosing of the sixth cohort is ongoing in a multi-center, phase 1, dose-escalation trial assessing the intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas. A study of CBL0137 safety and efficacy in hematological malignancies is planned.
A formal interim analysis of the 19 patients enrolled in the first six cohorts of the ongoing oral administration study indicated that the study medication was well tolerated at all investigated dose levels. The observation of drug exposure in plasma documented high oral bioavailability (typically estimated to be ? 50%). To date, no dose-limiting toxicities have been observed with either oral or intravenous administration through the highest CBL0137 dose levels tested. Heavily pretreated patients with advanced cancers of the esophagus, colon, breast, cervix, and prostate have had stable disease for periods ranging from 4 to 6 months. Peripheral blood mononuclear cells (PBMC) from evaluable blood samples have shown pharmacodynamic effects consistent with the expected mechanism of action of CBL0137.
Andrei Gudkov, Ph.D., D. Sci., Chief Scientific Officer of CBLI and Senior Vice President of Basic Science of Roswell Park Cancer Institute, commented, "We are delighted with the progress of the CBL0137 development program. CBL0137 represents a unique new drug that addresses nearly universal but difficult-to-target pathways involved in cancer progression and survival. CBL0137 trapping of the chromatin remodeling complex, Facilitates Chromatin Transcription (FACT), in DNA inhibits nuclear factor-kappa-B (NF-kB), a factor essential for survival of tumor cells, while enhancing p53-mediated tumor cell death. CBL0137 has demonstrated preclinical efficacy against broad spectrum of solid tumors and hematological malignancies, including cancers resistant to currently available drugs, and now is showing evidence of pharmacological activity in patients at nontoxic doses."
Langdon Miller, MD, Strategic Medical Advisor to CBLI and Incuron, stated, "The CBLI and Incuron development teams are pleased to be able to translate the very promising CBL0137 preclinical data to the clinic. Dose escalation continues in the ongoing studies of the oral and intravenous formulations of CBL0137 in patients with solid tumors. A successful meeting with the U.S. Food and Drug Administration (FDA) in December 2014 opens the opportunity to initiate an additional Investigational New Drug Application (IND) and move forward in 2015 with a multicenter trial of CBL0137 in patients with hematological cancers."
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company's lead product candidates are entolimod, which is being developed as radiation countermeasure and a potential cancer treatment, and Curaxin CBL0137, our lead oncology product candidate. The company conducts business in the United States and in the Russian Federation through our three operating subsidiaries, Incuron, LLC, BioLabs 612, LLC and Panacela Labs, Inc. The Company maintains strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, and the Children's Cancer Institute Australia. 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 the conduct and results of our various clinical trials; the efficacy of our therapeutic products; our ability to successfully complete planned clinical studies; and our ability to obtain regulatory approval for our therapeutic products. 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 risks inherent in the early stages of drug development and in conducting clinical trials; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts. 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.
Cleveland BioLabs, Inc.
Vice President, Investor Relations