GenSpera Obtains Authorization for G-202 Phase II Trial in the United Kingdom
Company:GenSpera, Inc.Craig Dionne, PhD, CEO, 210-479-8112orInvestors:Cameron AssociatesPaul Henning, 212-554-5462orMedia:Planet CommunicationsDeanne Eagle, 917-837-5866
GenSpera, Inc. (OTCBB:GNSZ) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) 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, which was approved by the United States (US) Food and Drug Administration in July 2012, will be conducted at up to six sites in the US and the UK and will enroll up to 40 patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer. GenSpera plans to initiate the UK study pending clearance from the Multicentre Research Ethics Committee (MREC).
“This authorization for GenSpera’s first clinical trial outside of the US is an important milestone for our company and underscores our commitment to an international clinical development program for G-202, in parallel with the US program,” said Craig Dionne, PhD, GenSpera CEO and President.”
GenSpera, Inc. is an oncology company focused on developing 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 targets the release of the drug only within the tumor. Unlike standard cancer drugs, thapsigargin has been shown to kill cells independently of their division rate, which may provide an effective approach to kill 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 candidate, 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 in the United States and United Kingdom for initiation of a multi-center Phase II trial in patients with chemotherapy-naïve, 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 Board or .
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This news release may contain forward-looking statements. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of GenSpera’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties will be detailed from time to time in GenSpera’s periodic reports filed with the Securities and Exchange Commission.