GenSpera receives FDA clearance to commence G-202 Phase II trial in prostate cancer

Jul 31 2012

GenSpera, Inc. (OTCBB:GNSZ) announced that the U.S. Food and Drug Administration (FDA) has cleared for initiation a Phase II human clinical trial of its lead compound, G-202, in the treatment of prostate cancer patients who have failed prior hormonal therapy. The Phase II study is anticipated to be conducted at up to six sites in the United States and the United Kingdom, and is expected to involve the aggregate enrollment of up to 40 patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer. Commencement of the trial and enrollment of patients is pending approval from the respective Institutional Review Boards at the participating sites.

"We are excited that G-202 will be delivered to patients who have prostate cancer, where we expect its ability to target slow-growing cancer cells should be particularly effective," said Samuel R. Denmeade, MD, GenSpera's Chief Clinical Advisor and Co-Founder. "We have spent two decades developing a 'molecular grenade' that is designed to be activated only within the tumor. It is gratifying to see it progress to advanced clinical studies." Dr. Denmeade is also Professor of Oncology, Urology, Pharmacology, and Molecular Sciences at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

"We are pleased that G-202 has received clearance from the FDA to initiate our Phase II study in prostate cancer. The trial, which is anticipated to be conducted at multiple sites in the United States and the United Kingdom, is part of our corporate strategy to gain entry into the international oncology community early in the clinical development of G-202," said Craig Dionne, PhD, GenSpera CEO and President.