According to the trial protocol, enrollment of subjects of the main cohort may be initiated only if a limited number subjects of the first cohort experience adverse events. This criterion has been achieved, enabling enrollment into the main cohort.
“CBLC102 is the most advanced compound in our anticancer (Curaxin) pipeline and presents a significant and unique market opportunity as a potential oral therapy for cancer,” commented Michael Fonstein, Cleveland BioLabs president and CEO.
The phase II study will involve a total of 31 patients with advanced, refractory prostate cancer. Primary endpoints for the 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.
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.
The FDA has assigned orphan-drug status to treatments for androgen-independent prostate cancer. The company plans to start additional phase II studies of Curaxin CBLC102 in renal cell carcinoma and multiple myeloma in 2007.