FDA Approved GenSpera to Start G-202 Phase II Trial in Prostrate Cancer

GenSpera, Inc. introduced that the U.S. Food and Drug Administration has cleared for initiation a Phase II human clinical trial of the lead compound, G-202, within the remedy for prostate cancer affected individuals who have failed past hormonal therapy.

The Phase II study is supposed to remain conducted at up to six sites in the United States and of course the United Kingdom, and is anticipated to contain the combination enrollment of up to 40 affected individuals with chemotherapy-naive, metastatic castrate-resistant prostate cancer. Beginning of the trial and enrollment of affected individuals is pending approval direct from respective Institutional Review Boards towards the participating sites.

"We are enthusiastic that G-202 to be completed to affected individuals who have prostate cancer, in which we desire its skill to target slow-growing cancer cells ought to be particularly most effective," said Samuel R. Denmeade, MD, GenSpera's Chief Clinical Advisor and Co-Founder.

"We are delighted that G-202 has got clearance direct from FDA to start our Phase II study in prostate cancer. The trial, which is supposed to remain conducted at multiple sites in the United States and the United Kingdom, is a small part of our corporate technique to gain entry into the worldwide oncology community at the beginning of the clinical development of G-202," said Craig Dionne, PhD, GenSpera CEO and President.