Positive Phase 1 results in adult glioma patients supported pediatric
brain cancer clinical program—now in pivotal studies
SEATTLE–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/BLZ100?src=hash" target="_blank"gt;#BLZ100lt;/agt;–Blaze
Bioscience, Inc., the Tumor Paint Company®, a
biotechnology company dedicated to improving the lives of cancer
patients through development and commercialization of products for
fluorescence guided surgery, today announced the publication of Phase 1
results in the peer-reviewed journal Neurosurgery. The
publication entitled “Phase 1 Safety, Pharmacokinetics, and Fluorescence
Imaging Study of Tozuleristide (BLZ-100) in Adults with Newly Diagnosed
or Recurrent Gliomas” by Patil et al is available online in Neurosurgery
Now!.
The publication reports data from 17 subjects in a single dose,
dose-escalation, open-label clinical trial conducted at Cedars-Sinai
Medical Center in Los Angeles and the NEWRO Foundation in Brisbane,
Australia. The primary objective of the study was to evaluate the safety
and tolerability of tozuleristide in adult subjects with glioma
undergoing surgery. Tozuleristide was found to be well tolerated at all
tested doses with no dose limiting toxicities observed. A maximum
tolerated dose was not reached. Exploratory imaging studies were
conducted with the FLUOBEAM®800 (Fluoptics), Odyssey CLx
(LI-COR Biosciences) and SIRIS (Teal Light Surgical) imaging devices.
Fluorescence signal was detected in both high- and low-grade tumors and
was visible from 3 hours to 27 hours post dosing.
“Tozuleristide fluorescence visualized with a high-resolution imaging
system shows great promise as a tool to increase extent of resection for
both high- and low-grade gliomas while preserving critical normal brain
tissue. Improved resection is the single most important factor for
improving survival and quality of life in brain tumor patients. Based on
these encouraging results, further clinical trials are definitely
warranted,” said Dr. Adam Mamelak, MD, neurosurgeon at Cedars-Sinai and
senior author on the publication.
“The positive data in adult glioma subjects has paved the way for our
broader pediatric brain cancer clinical trials,” said Dr. Dennis Miller,
Blaze Bioscience SVP of Development. “The study also pointed out the
need for improved imaging devices for brain cancer surgery applications
which led to the development of the Canvas Imaging System being used in
our ongoing pivotal study.”
About BLZ-100 (tozuleristide)
BLZ-100 (tozuleristide) is the first product candidate from Blaze’s
Tumor Paint platform and consists of a targeting peptide and a
fluorescent dye, which emits light in the near-infrared (NIR) range.
Tumor Paint products are designed to provide real-time, high-resolution
intraoperative visualization of cancer cells throughout surgery,
potentially enabling more precise, complete resection of cancer while
sparing normal adjacent tissue. BLZ-100 has been tested in four Phase 1
clinical trials and has demonstrated 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.
BLZ-100, an investigational agent, is being evaluated in a pivotal Phase
2/3 clinical study in pediatric central nervous system tumors. More
details about ongoing trials are available at www.clinicaltrials.gov.
About the Canvas Imaging System
The Canvas Imaging System is an investigational medical device designed
to provide high-sensitivity detection of NIR light in the operating room
under ambient light conditions. The Canvas Imaging System was developed
and is manufactured by Teal Light Surgical, Inc. (a wholly owned
subsidiary of Blaze Bioscience, Inc.). The first Canvas Imaging System
under development is adapted for use with surgical microscopes and
detects both BLZ-100 and indocyanine green (ICG).
About Blaze Bioscience
Blaze Bioscience, Inc. is a privately held biotechnology company
dedicated to improving the lives of cancer patients. Blaze was founded
in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred
Hutchinson Cancer Research Center and Seattle Children’s Hospital, and
Heather Franklin, a former senior executive at ZymoGenetics. Blaze is
working to develop Tumor Paint products and related therapeutics.
Surgery is first-line therapy for most solid tumor cancers and Tumor
Paint products have the potential to improve cancer surgery by providing
real-time, high-resolution visualization of cancer cells throughout
surgery. For additional information, please visit www.blazebioscience.com.
Contacts
Brenda Majercin
SVP of Investor Relations and Communications
Blaze
Bioscience, Inc.
(206) 535-8144
brenda.majercin@blazebioscience.com