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"We are encouraged by the positive results of this second study whichfurther underscores BZL101's safety at higher doses and highlights itspotential as an effective, novel, oral treatment for the more than 45,000women who are diagnosed with this late stage breast cancer each year," saidlead author, Dr. Alejandra Perez, Director of the Breast Cancer Center at theMemorial Regional Hospital Cancer Institute. "While safety and maximumtolerability are the primary endpoints of the trial, BZL101 also showed earlyclinical efficacy, including one patient who has been stable for 13 months andshows radiographic evidence of tumor shrinkage."
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The study is being conducted by investigators at Duke University, ColumbiaPresbyterian Medical Center, University of Chicago, University of TexasSouthwestern Medical Center, Ohio State University, Montefiore Medical Center,Cancer Research Network and Memorial Regional Cancer Institute incollaboration with scientists at Bionovo. The study is a Phase 1/2 trial, andis currently in the Phase 1 Dose Escalation component, and is expected toprogress to the Phase 2 component and full recruitment during the thirdquarter of this year.
"Based on the promising data from the early clinical trials of BZL101, weare excited to transition to our FDA-approved Phase 2 program later thisyear," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "Ibelieve this trial's results further validate the potential for a novel, oralanticancer drug with a unique mechanism of action that selectively targetcancer cells without affecting normal cells as evidenced by our low toxicityand early clinical efficacy. Due to BZL101's favorable results to date,Bionovo will consider studying BZL101 as the first non-hormonal, oral adjuvantfor early breast cancer."
Study Design and Results
In this open-label, dose escalation trial, 20 patients with histologicallyconfirmed metastatic breast cancer and measurable disease were treated withoral BZL101 until disease progression or toxicity. Mean age was 60 years andpatients had failed an average of 3.1 prior chemotherapy treatment regimenssince diagnosis with metastatic breast cancer. Primary endpoints of the studyinclude safety, toxicity and tumor response as defined by RECIST (ResponseEvaluation Criteria In Solid Tumors), a set of published criteria thatdetermine when a tumor responds, remains stable or progresses.
The trial is currently ongoing and three different doses of BZL101 havebeen found to be safe and well tolerated. A fourth cohort of patients iscurrently being enrolled to the trial in order to determine the maximumtolerated dose that will be tested in the Phase 2 clinical trial later thisyear. There were no serious adverse events (SAEs) associated with BZL101treatment. Patients were able to tolerate BZL101 therapy well and compliancewith treatment was 93% of prescribed doses. The most frequently reportedBZL101-related adverse events were: diarrhea (40%), nausea (30%), headache(20%), and increased amino alanine transferase (20%).
Twelve patients were evaluable for response according to RECIST. Five ofthe 12 patients had stable disease (SD) for >90 days (42%) and one patient,currently on study, has had SD for >170 days. An additional patient has beenstable for 13 months and had radiographic evidence of tumor shrinkage.
About BZL101
BZL101 is an oral drug d
