On June 15, 2017 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company dedicated to improving the lives of cancer patients, reported that clinical data from the company’s Phase 1 study of Tumor Paint BLZ-100 (tozuleristide) in pediatric brain cancer patients were presented at the 4 th Biennial Pediatric Neuro-Oncology Basic and Translational Research Conference in New York, NY (Press release, Blaze Bioscience, JUN 15, 2017, View Source [SID1234519593]). Schedule your 30 min Free 1stOncology Demo! The presentation, titled "Phase 1 safety, pharmacokinetic and imaging study of BLZ-100 Tumor Paint in pediatric brain tumor patients", was presented by the study’s principal investigator, Sarah Leary, M.D., pediatric oncologist at Seattle Children’s Hospital.
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The Phase 1 experience in pediatric brain cancer patients with the investigational product BLZ-100 (tozuleristide) through the dose escalation phase of the study was presented. This investigational agent has the potential to aid surgeons in achieving maximal safe surgical resection, an essential component of pediatric brain cancer treatment. Dr. Leary provided details on the safety and clinical proof of principle data for BLZ-100 to detect pediatric brain tumors in real time during surgery in 15 patients from the 5 dose escalation cohorts. BLZ-100 was well tolerated in the dose levels studied with tumor fluorescence observed in a majority of evaluated tumors. Data supported dose selection for the ongoing dose expansion phase of the study in which is currently open to enrollment.
"We are continually inspired by our pediatric patients and their families, and aim to provide the best outcomes possible for these children," said Dr. Leary. "Successful surgery is a foundation of treatment and extent of resection is the single best predictor of survival in pediatric patients with brain tumors. I believe BLZ-100 as an aid to surgery has tremendous potential and look forward to further clinical testing in the pediatric population."
"The results to date from the ongoing Phase 1 study are very encouraging," said Heather Franklin, Blaze Bioscience President and CEO. "Current treatment for pediatric brain cancer all too often has a devastating impact on subsequent childhood development. Disease symptoms in conjunction with harsh treatment options such as radiation therapy and chemotherapy have lasting negative effects on a developing body. We are dedicated to improving pediatric brain cancer surgery to achieve better survival and quality of life for children with brain cancer."
About the Phase 1 pediatric brain cancer study
The open-label Phase 1 dose escalation and expansion study is evaluating BLZ-100 in pediatric subjects with primary central nervous system tumors. The study is being conducted at Seattle Children’s Hospital under the direction of principal investigator Sarah Leary, M.D. The dose escalation part of the study has enrolled 15 pediatric patients at five pre-specified dose levels to evaluate safety and tolerability of BLZ-100 and provide clinical proof of principle data for BLZ-100 to detect tumors in pediatric subjects. The dose expansion part of the study is ongoing.
Further information on this clinical trial can be found at: View Source
About BLZ-100
BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide) and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are
2 designed to provide real-time, high-resolution intraoperative visualization of cancer cells, potentially enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types. BLZ-100, an investigational agent, is in Phase 1 clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumors. BLZ-100 has achieved clinical proof of concept in brain, breast and skin cancers. Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. More details about on-going trials are available at www.blazebioscience.com or www.clinicaltrials.gov.