Cleveland BioLabs, Inc. (CBLI) announced that it has achieved all objectives in a phase I trial on oncology candidate, CBL0102 (quinacrine).
The trial (n=32) was conducted in patients suffering from advanced cancers. We note that CBL0102 is being developed by Incuron LLC, a joint venture between Bioprocess Capital Ventures and Cleveland BioLabs.
The primary endpoint of the study was to evaluate the maximum tolerated dose and the dose-limiting toxicities of CBL0102 in patients with advanced cancers while the secondary endpoints were to evaluate CBL0102's safety and pharmacokinetics.
The patients received sequentially higher starting doses of CBL0102. It was observed that CBL0102 successfully achieved both the primary and secondary objectives.
It was also observed that CBL0102 was generally well tolerated. Consequently, a recommended dose of 400 mg/day was established for a phase II study.
We remind investors that CBL0102 enjoys orphan drug status in the U.S. for the treatment of hepatocellular carcinoma since Oct 2012.
Meanwhile, Case Comprehensive Cancer Center, in cooperation with the National Cancer Institute, recently initiated a phase I/II study evaluating the safety and efficacy of the combination treatment with Roche's (RHHBY) Tarceva and CBL0102 in patients suffering from stage IIIB-IV non-small cell lung cancer.
We are encouraged by the positive results of the phase I trial. Cleveland BioLabs is now looking for a partner for the potential development of CBL0102 as well as support investigator-initiated trials.
The pipeline at Cleveland BioLabs looks interesting. The lead candidates of the company include Entolimod, which is being developed as radiation countermeasure and a potential cancer treatment and Curaxin CBL0137 for cancer.