This open label trial is evaluating the safety and efficacy of Curaxin CBLC102 for use in treating patients with hormone-refractory metastatic prostate cancer. The planned enrollment of 32 patients from four medical centers in the US was completed on April 29, 2008. Patients were evaluated prior to treatment with Curaxin CBLC102 and at one-month intervals for a maximum of six months.
The goals of the trial were to confirm the safety and tolerability of CBLC102 in patients with hormone-refractory metastatic prostate cancer and to evaluate the efficacy of CBLC102 in this patient population through assessments of PSA levels, reductions in tumor size and disease free survival periods. The results of this trial are anticipated to be available in the fourth quarter of 2008.
Michael Fonstein, president and CEO of Cleveland BioLabs, said: “Curaxin CBLC102 is the most advanced compound in our anti-cancer pipeline and presents a significant and unique market opportunity as a potential oral therapy for cancer. We are hopeful that this trial will provide preliminary evidence that this therapeutic approach may benefit patients with advanced prostate cancer.”