BLZ-100 (tozuleristide) was found to be well-tolerated by patients and to make breast cancer tumors more easily seen during surgery in a Phase 1 clinical trial, Blaze Bioscience announced. BLZ-100 was used to “paint” tumors to better guide surgeons while operating.
Results of the trial (NCT02496065) were presented at the American Society of Breast Surgeons annual meeting in Las Vegas, Nevada, last month.
BLZ-100 is a drug that consists of a dye that emits light in the near-infrared range, and an “optide,” or kind of peptide, a small chemical that specifically attaches to solid tumors, “painting” them with dye so that they can be easily seen. The ability to see cancer cells during surgery should make tumor detection more accurate and allow for more precise and complete surgical removal of cancer — while sparing surrounding normal tissue. It is the first in a line of product candidates in Blaze’s Tumor Paint platform.
The study included 23 patients with breast cancer that was either invasive (spread within the breast) or limited to one location, and was found to be well-tolerated. The drug’s ability to outline tumors was shown, supporting BLZ-100 as a visual aid in detecting breast cancer sites. Participants received one of two dose levels, and safety data — along with clinical proof that BLZ-100 can detect breast cancer in the laboratory after tissue is removed and during surgery — were documented.
BLZ-100 is also being tested in gliomas (a kind of brain cancer), central nervous system tumors in children and skin neoplasms (abnormal masses of tissue that may be benign or malignant).
“Our ultimate goal is to provide the best surgical outcomes for our patients. Initial results support the potential of BLZ-100 to detect cancerous tissue and assess margin status in real time,” said Kristi Harrington, MD, the study’s principal investigator and breast surgeon affiliated with Overlake Hospital Medical Center in Washington, in a press release. “I look forward to further clinical testing of BLZ-100 as an agent which could provide surgeons and pathologists with the means to reduce the rate of positive margins and decreased re-excision rates.”
A review study outlining the pharmacokinetic and toxicology profile of BLZ-100 in animals, “Nonclinical Profile of BLZ-100, a Tumor Targeting Fluorescent Imaging Agent,” was published in the International Journal of Toxicology in March.
“The Phase 1 BLZ-100 results in breast cancer are encouraging,” said Heather Franklin, president and CEO of Blaze Bioscience. “This adds breast cancer to the growing list of cancers for which BLZ-100 has demonstrated clinical proof of concept.”