Results of OPT-822/821 (822-001) Phase 1 Trial

Here is some information I found on the phase 1 trial of the clinical trial I am considering.  Mine will be the phase 2 of this same trial:

MSKCC completed Phase 1 safety studies of OPT-822/821 in prostate cancer patients and breast cancer patients in 1999 and
2001, respectively. In these studies, OPT-822/821 appeared to be well tolerated and to stimulate responses to tumor antigens.
Twenty-one of 27 metastatic breast cancer patients treated with OPT-822/821 in the study survived after four years, with 48% of
patients surviving more than nine years following completion of the Phase 1 safety study.



In January 2011, OBI initiated a Phase 2/3 clinical trial of OPT-822/821. This study, referenced as OPT-822-001, is designed
as a multi-center trial with sites in Taiwan, South Korea, Hong Kong and Singapore. The Phase 2/3 clinical trial is expected to enroll
up to 342 patients. The primary endpoint is the progression free survival rate from the time of randomization until disease progression.
The secondary endpoint is the overall survival rate from the time of enrollment. Patients will receive a total of up to nine injections of
OPT-822/821 plus Cyclophosphamide, or placebo plus Cyclophosphamide (2:1 randomization) over a treatment period of nine months
with study follow-up at eight week intervals until disease progression or up to two years, as well as survival follow-up until five years
from randomization.

Source: http://216.139.227.101/interactive/optr2010/pf/page_043.pdf