GenSpera Cleared to Initiate Phase II G-202 Trial in Prostate CancerGenSpera, Inc.NewsRx.com
By a News Reporter-Staff News Editor at Clinical Trials Week -- 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-naive, 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 (see also GenSpera, Inc.).
"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. About GenSpera GenSpera, Inc. is a development-stage oncology company focused on therapeutics that have the potential to deliver a potent, unique and patented drug directly to tumors. GenSpera's technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug delivery system that appears to release the drug only within the tumor. Unlike standard cancer drugs, thapsigargin has been shown to kill cells independently of their division rate, thus providing the potential for an effective approach to kill all fast- and slow-growing cancers and cancer stem cells.
GenSpera has completed a Phase Ia dose-escalation safety and tolerability study with its lead drug, G-202, at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, the University of Wisconsin Carbone Cancer Center, and the Cancer Therapy and Research Center at the University of Texas Health Science Center in San Antonio. The study has continued into a Phase Ib dose refinement study at the same clinical sites. G-202 has been cleared for initiation of a multi-center Phase II trial in patients with chemotherapy-naive, metastatic castrate-resistant prostate cancer. GenSpera expects to initiate multiple Phase II trials of G-202 in several different types of cancer. The initiation of the Phase II trials at each site is subject to the approval of their respective Institutional Review Boards.
GenSpera's pipeline of drugs also includes G-114, G-115 and G-301, all of which directly target prostate cancer.
Keywords for this news article include: Therapy, Oncology, Technology, FDA Actions, GenSpera Inc., Prostate Cancer, Government Agencies, Prostatic Neoplasms, Offices and Entities, Clinical Trial Research.
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