Clinical Trial of CBL0102

CBL0102 is a clinical stage oncology drug. It is an orally administered low-molecular compound.

 

CBL0102 is a Quinacrine, a compound with a long history of use in humans as a treatment for malaria, osteoarthritis and autoimmune disorders. More recently, it has been shown that CBL0102 that interferes with a novel molecular target, FACT (Facilitates Chromatin Transcription) complex resulting in simultaneous NF-kB suppression, Heat Shock Factor 1 suppression and p53 activation. Quinacrine has shown antitumor activity in subcutaneous human xenografts of renal cell carcinoma, prostate adenocarcinoma and fibrosarcoma. Antitumor effects of CBL0102 were shown in vitro in several human tumor cell lines including melanomas, lung adenocarcinoma, mammary gland adenocarcinoma and colon carcinoma.

 

In 2008, a Phase II study was concluded in the United States in 31 patients with late stage, hormone refractory (androgen-independent) prostate cancer that had not responded to or relapsed following previous hormonal therapy and/or chemotherapy. The study results showed that one patient had a partial response, while 6 patients exhibited a decrease or stabilization in the rate of cancer progression. CBL0102 was well-tolerated and there were no serious adverse events attributed to the drug.

 

Due to particularly high accumulation of CBL0102 in the liver, in 2010 Incuron conducted a multi-center open-label, dose escalation, Phase 1b safety and tolerability study in patients with liver tumors of different origin. The study was approved by the Ministry of Health and Social Development of the Russian Federation. The objectives of the study included determination of the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of CBL0102 in patients with primary advanced hepatic carcinomas or liver metastases of solid tumors of epithelial origin, and evaluation of patient response. 1b Phase clinical study, which is now nearly complete, included 32 patients (out of 37 patients which passed the screening). 13 patients underwent 8-week treatment. Of these, 4 patients exhibited stabilization. There were no serious adverse events observed during the dose-escalation in different dose cohorts. The Phase 1b clinical study results shown that study was successful in achieving its primary objective.

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