University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

Dec 15 2009

GenSpera, Inc. (OTCBB: GNSZ) announced today that the Institutional Review Board (IRB) at the University of Wisconsin, in Madison, WI, has approved a Phase I study of its target activated pro-drug, G-202, for the treatment of cancer. The FDA (US Food and Drug Administration) approved the study in September. GenSpera expects to enroll the first study patient early in the first quarter of 2010.

The G-202 Phase I study is designed to enroll up to thirty patients with cancers that have progressed after treatment with other anti-cancer agents. The primary endpoints of the open-label, dose-escalation study are to determine the safety, tolerability and pharmacokinetics of the drug, although the design allows the collection of efficacy data as well. Patients will also accrue at a second major cancer center, subject to its IRB approving the study.

“This IRB approval is another important milestone for GenSpera as we now move into full-fledged clinical stage operations with our lead drug, G-202,” said Dr. Craig Dionne, CEO, GenSpera, Inc. “We look forward to working closely with our Phase I sites, which are internationally recognized leaders in clinical cancer research.”

“We are excited that this clinical trial has been activated at the University of Wisconsin Carbone Cancer Center,” said Dr. George Wilding, Director of the Carbone Cancer Center and the Principal Investigator (PI) for the study. “G-202 is a novel approach to the treatment of cancer and we hope that it has a significant effect for those patients whose lives are affected by this disease.”

Patients interested in enrolling in the G-202 trial may contact the University of Wisconsin Carbone Cancer Center Connect line at 800-622-8922.

SOURCE GenSpera, Inc.