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First BLZ-100 clinical study under open U.S. IND
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Clinical program begins in lead indication and expands beyond skin cancer
SEATTLE, WA, USA I September 25, 2014 I Blaze Bioscience, Inc., a biotechnology company focused on guided cancer therapy, announced today that the company has received clearance from the United States Food and Drug Administration (FDA) for the first Phase 1 clinical study under their Tumor Paint BLZ-100 Investigational New Drug application (IND). The Phase 1b study entitled “A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects with Glioma Undergoing Surgery” will enroll up to twenty-one (21) patients and is being conducted at sites in the U.S. and Australia.
“The need for improved brain cancer therapy—starting with surgery—is tremendous. The Phase 1b study marks the initiation of our clinical program in this orphan indication,” said Dennis Miller, Ph.D., Blaze Bioscience’s Senior Vice President of Development. “We are starting with glioma, but our ultimate aim is to help patients with many different types of cancer by improving surgeons’ ability to achieve more complete surgical resection.”
“Initiating our U.S. clinical program under our open IND is a key milestone for Blaze. We believe this Phase 1b study in glioma could demonstrate clinical proof of principle for BLZ-100 and the Tumor Paint platform,” said Blaze Bioscience President and CEO Heather Franklin.
BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (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 has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, colorectal, skin, and sarcomas.
For additional information on the brain cancer clinical trial, please visit http://clinicaltrials.gov/show/NCT02234297.
About Blaze Bioscience
Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 and is working to develop Tumor Paint™ products and Optide-based guided cancer therapeutics. Surgery is first line therapy for most solid tumor cancers and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. Blaze has an ongoing collaboration with the Fred Hutchinson Cancer Research Center focused on the discovery and development of Optide-based products for use as guided therapeutics. For additional information, please visit www.blazebioscience.com.
SOURCE: Blaze Bioscience
Post Views: 735
-
First BLZ-100 clinical study under open U.S. IND
-
Clinical program begins in lead indication and expands beyond skin cancer
SEATTLE, WA, USA I September 25, 2014 I Blaze Bioscience, Inc., a biotechnology company focused on guided cancer therapy, announced today that the company has received clearance from the United States Food and Drug Administration (FDA) for the first Phase 1 clinical study under their Tumor Paint BLZ-100 Investigational New Drug application (IND). The Phase 1b study entitled “A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects with Glioma Undergoing Surgery” will enroll up to twenty-one (21) patients and is being conducted at sites in the U.S. and Australia.
“The need for improved brain cancer therapy—starting with surgery—is tremendous. The Phase 1b study marks the initiation of our clinical program in this orphan indication,” said Dennis Miller, Ph.D., Blaze Bioscience’s Senior Vice President of Development. “We are starting with glioma, but our ultimate aim is to help patients with many different types of cancer by improving surgeons’ ability to achieve more complete surgical resection.”
“Initiating our U.S. clinical program under our open IND is a key milestone for Blaze. We believe this Phase 1b study in glioma could demonstrate clinical proof of principle for BLZ-100 and the Tumor Paint platform,” said Blaze Bioscience President and CEO Heather Franklin.
BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (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 has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, colorectal, skin, and sarcomas.
For additional information on the brain cancer clinical trial, please visit http://clinicaltrials.gov/show/NCT02234297.
About Blaze Bioscience
Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 and is working to develop Tumor Paint™ products and Optide-based guided cancer therapeutics. Surgery is first line therapy for most solid tumor cancers and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. Blaze has an ongoing collaboration with the Fred Hutchinson Cancer Research Center focused on the discovery and development of Optide-based products for use as guided therapeutics. For additional information, please visit www.blazebioscience.com.
SOURCE: Blaze Bioscience
Post Views: 735
