Cleveland BioLabs & Incuron Announce Orphan Drug Status
Cleveland BioLabs, Inc. and Incuron, LLC, a joint venture between the company and Bioprocess Capital Ventures, recently announced that curaxin CBL0102 (quinacrine) has been granted Orphan Drug status by the US FDA for treatment of hepatocellular carcinoma.
A multi-center Phase I trial of CBL0102 is ongoing in the Russian Federation 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 trial is dosing the sixth cohort in its dose-escalation arm and, subsequent to the completion of the dose-escalation arm, will enroll an efficacy arm.
There are approximately 30,000 US and 45,000 EU annual cases of hepatocellular carcinoma, with an overall survival rate of approximately 15%. CBL0102 is an orally administered small molecule that acts by blocking activity of chromatin remodeling complex FACT, resulting in simultaneous modulation of three signal transduction pathways (p53, NF-kappaB and heat shock response) commonly deregulated in cancer.
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 www.incuron.com.
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 www.cbiolabs.com.
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