Cleveland BioLabs initiates prostate cancer study

Curaxin CBLC102 has been used in the past to treat malaria and has demonstrated efficacy in vitro, in animal models, and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal cell carcinoma and soft-tissue sarcoma.

“CBLC102 is the most advanced compound in our anticancer pipeline and presents a significant and unique market opportunity as a potential oral therapy for cancer. Its status as a previously approved and historically used therapy for malaria establishes an accelerated pathway for development due to its proven safety profile,” commented Cleveland BioLabs president and CEO, Michael Fonstein.

Some recent studies have yielded modest improvements in survival rates for prostate cancer, however androgen-independent metastatic prostate cancer remains essentially incurable. The FDA has assigned orphan-drug status to treatments for androgen-independent prostate cancer, which rewards developers with tax reductions and marketing exclusivity on approved drugs for an extended time period.

Primary endpoints for the phase II study are reduction in PSA levels, reduction in tumor size, and disease-free survival. The duration of the study is two years however certain preliminary data may be available earlier.