Cleveland BioLabs and Incuron Announce Russian Regulatory Allowance of IND for Phase 1B Trial of CBLC137
BUFFALO, N.Y., April 30, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (CBLI) and its majority-owned subsidiary, Incuron, LLC today announced that a new Investigational New Drug (IND) application for clinical testing of CBLC137 was opened with the regulatory authority of the Russian Federation.
A Phase 1b, dose escalation study of the oral formulation of CBLC137 in subjects with advanced solid tumors that are resistant or refractory to standard care treatment, will be conducted at five sites in the Russian Federation. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBLC137. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and anti-tumor response to CBLC137. The study includes a dose escalation arm of up to 36 patients divided into six cohorts, and a dose confirmation arm with an additional nine to twelve patients to be enrolled at the selected therapeutic dose.
The lead center for the study is the Russian Oncological Scientific Center n.a. N.N. Blokhin (ROSC) in Moscow, a leading oncology center in Russia. The national coordinator for the study is Professor S.A. Tyulyandin, MD, D.Med.Sc., Deputy Director of Clinical Oncology and Director of Clinical Pharmacology and Chemotherapy at ROSC. Dr. Tyulyandin is one of the leading experts in cancer chemotherapy therapy in Russia. Innovative methods for the treatment of different malignant neoplasms have been developed under his leadership.
Curaxins are synthetic small molecules designed to target FACT (Facilitates Chromatin Transcription) complex, thereby affecting multiple molecular pathways commonly deregulated in cancer (Gasparian, et al. Curaxins: anti-cancer compounds that simultaneously suppress NF-kB and activate p53 by targeting FACT. Science Translational Medicine 2011 Aug 10; Volume 3, pp. 1-12). This multi-targeted mechanism of action induces apoptosis (regulated cell death) in a broad range of human tumor cell types and sensitizes tumor cells to the apoptosis-inducing effects of other anti-cancer treatments.
Andrey Leonov, Chief Executive Officer of Incuron, LLC, commented, "We are excited to start clinical trials with CBLC137, a proprietary new molecular entity. This initial trial is expected to generate valuable input on the future development of CBLC137. We believe that the ability of curaxins to simultaneously target several molecular pathways makes them very promising drug candidates that may be effective against a wide spectrum of human malignancies. In addition to being a major step forward in the development of this drug, our success in opening an IND with the Russian authorities for CBLC137 is very significant from a business perspective, since it marks a funding milestone for our partner, Bioprocess Capital Ventures."
An intravenous formulation of CBLC137 is currently being developed to further optimize its bioavailability, with plans to commence a Phase 1 clinical trial in the United States as soon as formal preclinical toxicology and other preparations supporting an IND filing are completed and the IND application is cleared by FDA.
About Incuron, LLC
Incuron, LLC is a Russian Federation based joint venture between Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures," and Cleveland BioLabs, Inc. Bioprocess Capital Ventures is a Russian Federation Venture Capital Fund managed by " Bioprocess Capital Partners , LLC," which was founded by several Russian investors including " Russian Venture Company ," JSC and a state corporation VneshEconomBank (VEB). The Fund focuses on investments in innovative projects in the pharmaceutical, biotechnology, and fine chemistry sectors of the economy in the Russian Federation. Incuron's strategy includes preclinical and clinical development of breakthrough biotechnologies discovered by CBLI with the subsequent introduction of brand new anticancer drugs with novel mechanism of action (Curaxins) to both Russian and American markets. To learn more about Incuron, LLC, please visit the company's website at http://incuron.com/ .
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 direct acting anticancer agent. The Company has two subsidiaries, Incuron, LLC, and Pancela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute of 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 .
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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.
These factors include, among others, 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; the Company's failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company's ability to comply with various safety, environmental and other governmental regulations. 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, Director Investor Relations & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: firstname.lastname@example.org
Source: Cleveland BioLabs, Inc. 2012 GlobeNewswire, Inc.