Dec 1 2010
GenSpera, Inc. (OTCBB:GNSZ) announced its intention to expand its Phase I safety trial to study G-202 in relapsed, refractory cancer patients to the Cancer Therapy and Research Center (CTRC) at The University of Texas Health Science Center at San Antonio in San Antonio, TX. The expansion is dependent upon a successful review of the clinical protocol by the Health Science Center Institutional Review Board (IRB). The company anticipates admitting the first patient at this site in the first quarter of 2011.
“It will be an important milestone for the local biotech industry”
"We are delighted that CTRC will be joining us as an active and enthusiastic partner in the Phase I clinical trial of our lead compound, G-202. The center has a strong history of cancer drug development and has evaluated more than 20 drugs that have gone on to eventual approval by the FDA," said Craig Dionne, Ph.D., Chairman and CEO of GenSpera. "Their entry into the study will allow more rapid patient recruitment during the Phase Ib portion, in which we plan to expand enrollment at the maximum tolerated dose to get an early signal of potential activity in multiple cancer types. We are also delighted to facilitate access to G-202 to cancer patients in Southwest Texas."
"It will be an important milestone for the local biotech industry," said Susan Mooberry, Ph.D., interim director of the CTRC's Institute for Drug Development. "It highlights the GenSpera and CTRC partnership, and our commitment to the local community. And it's great for our patients."
The G-202 study, enrolling patients with cancers that have progressed after treatment with other therapies, has been underway since January, 2010, at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, in Baltimore, MD, and the University of Wisconsin Carbone Cancer Center, in Madison, WI. The primary endpoints of the open-label, dose-escalation study will be to determine the safety, tolerability and pharmacokinetics of the drug, although the design allows the collection of efficacy data as well.
SOURCE GenSpera, Inc.