Sixteen of the twenty-seven participants in the Phase 1B clinical trial were evaluable according to the Response Evaluation Criteria in Solid Tumors (RECIST). Of these sixteen evaluable women, five (31%) were stable on Bezielle for greater than 90 days and two (13%) were stable on Bezielle for greater than 180 days. Three patients (19%) on Bezielle had objective tumor regression, as evaluated by an independent radiology review.
Four patients discontinued from the study with stable disease, and of these four patients, one patient had objective tumor regression during 449 days of Bezielle treatment and continues to be stable off of study medication for a total of 600 days. A second patient who discontinued Bezielle treatment with stable disease continues to be stable for 832 days and has not started any new anticancer treatment. A third patient who discontinued with stable disease was stable for 591 days before evidence of progression. Further analyses on overall survival and progression-free survival will be performed.
Dose Escalation and Compliance
Overall compliance with study medication was excellent with 90% of prescribed doses taken. A maximum tolerated dose, as defined in study protocol, was never established despite dose escalation reaching a dose that was four times (40g/day) the previously evaluated Phase 1A dose.
"We are eager to advance Bezielle to Phase 2 clinical testing as the drug continues to have an improved safety profile over currently available chemotherapeutic agents, and shows encouraging clinical activity in a cohort of women who have been heavily pretreated for metastatic breast cancer," said Dr. Mary Tagliaferri, President and Chief Medical Officer, Bionovo.<
|SOURCE Bionovo, Inc.|
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