Date: 2015-06-04
Type of information: Initiation of patient enrollment
phase: 1
Announcement: initiation of patient enrollment
Company: Blaze Biosciences (USA - WA)
Product: BLZ-100 - chlorotoxin conjugated to indocyanine green dye
Action
mechanism: peptide. BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an optimized peptide, which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, 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, including brain, lung, breast, prostate, and colorectal.
Disease: brain tumor
Therapeutic area: Cancer - Oncology - Rare diseases
Country: USA
Trial
details: Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. The investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as they operate. This is a safety study to assess the safety of BLZ-100 in pediatric patients with central nervous system tumors. (NCT02462629)
Latest
news: * On June 4, 2015, Blaze Bioscience announced open enrollment for the first clinical study of Tumor Paint BLZ-100 in children with brain cancer. The study, entitled “A Phase 1 dose-escalation and expansion study of BLZ-100 in pediatric subjects with primary central nervous system tumors,” will be conducted at Seattle Children’s Hospital under the direction of principal investigator Dr. Sarah Leary.
The Phase 1 trial, which is operating under the company’s open Investigational New Drug (IND) application with the FDA, will enroll up to twenty-seven (27) patients, from infants through young adults under age 30 who have been diagnosed with a brain tumor, and will
evaluate the safety and imaging characteristics of BLZ-100.
