Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, dosed the first patient in a multi-center trial of curaxin CBLC102 (quinacrine) in patients with liver tumors in The Russian Federation.
The study is an open-label, dose escalation, Phase 1b safety and tolerability study in patients with liver metastases of solid tumors of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBLC102. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and response to CBLC102.
The study includes a dose escalation arm of up to 30 patients divided into five cohorts, with an additional six patients to be enrolled at the selected therapeutic dose. Patients will be treated with CBLC102 for eight weeks, with a loading dose administered in week 1 and maintenance doses administered in weeks 2-8. Dose escalation will be done gradually, starting with a loading dose of 300mg and a maintenance dose of 100mg. Recruitment is anticipated to take approximately six months, with overall duration of the study to last approximately 12 months.
The lead center for the study is the Russian Oncological Scientific Center (ROSC) in Moscow, a leading oncology center in Russia. The national coordinator for the study is Professor S.A. Tyulyandin, MD, D.Sc., Deputy Director of Clinical Oncology and Director of Clinical Pharmacology and Chemotherapy at ROSC. Dr. Tyulyandin is one of the leading experts in drug therapy of malignant tumors in Russia and is considered a recognized expert on chemotherapy. Complex methods for the treatment of malignant neoplasms of the testes, and breast, ovarian and other tumors have been developed under his leadership.
Curaxins are synthetic small molecules designed to simultaneously target major stress response pathways that are frequently deregulated in cancer. CBLC102 has a long history of use in humans as an anti-malarial drug. The first human anticancer trial with CBLC102 in hormone refractory (androgen-independent) prostate cancer was completed in 2008, demonstrating indications of activity and an acceptable safety profile.
Several publications have explored the mechanisms of action of CBLC102, including one study (Neznanov et al., Cell Cycle 8:23, 1-11; December 1, 2009) that examined the ability of CBLC102 to inhibit heat shock response in tumors, and another study (Guo et al., Oncogene, 2009, 28:1151-1161) which indicated that treatment of cancer cells with CBLC102 resulted in the inhibition of an additional molecular pathway (PI3K/Akt/mTOR) that is considered to be a highly relevant anticancer treatment target.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, commented, "We are excited to see curaxins moving into the clinic through the Incuron joint venture. This initial trial is expected to generate valuable input on the future direction for CBLC102, while Incuron continues preparations to begin clinical studies with the next generation curaxin molecules in both the United States and Russia. We believe that the unique 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."
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of 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.
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; 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.
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