Published on September 1, 2012 at 1:48 AM
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
Source: GenSpera, Inc.