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Blaze Bioscience Announces Initiation of First-in-Human Phase 1 Clinical Study of BLZ-100

2013年12月19日 PM10:25
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SEATTLE & MELBOURNE, Australia

Blaze Bioscience, Inc. and its subsidiary, Blaze Bioscience Australia Pty Ltd, today announced the initiation of the first Phase 1 clinical study of the first Tumor Paint product candidate, BLZ-100. The study, titled “A Phase I Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects with Skin Cancer,” will enroll up to 30 patients with basal cell carcinoma, squamous cell carcinoma, or amelanotic melanoma. The primary objective is to evaluate the safety and tolerability of BLZ-100 after a single intravenous injection of BLZ-100 administered prior to surgery. The study will also examine the pharmacokinetics of BLZ-100 and the fluorescent signal from skin tumors.

“Initiation of the first-in-human clinical trial just a little over two years after moving the technology out of my lab at the Fred Hutchinson Cancer Research Center is a tremendous accomplishment and marks a major milestone in the development of the Tumor Paint platform,” said Jim Olson, M.D., Ph.D., co-founder of Blaze.

“Skin cancer surgery is just one of many cancer surgery settings that we think could benefit from real-time fluorescent imaging using BLZ-100,” said Dennis Miller, Ph.D., Senior Vice President of Development. “Blaze anticipates initiating a U.S. clinical program in additional tumor types by the end of 2014.”

The study will be conducted at two sites: Q-Pharm Pty Limited and the dermatology clinic of Specialist Connect Pty Limited, both located in Brisbane, Queensland, Australia. Dr. Lynda Spelman of Specialist Connect is the Principal Investigator. Dr. Lauren Kunde and Dr. Paul Griffin are co-investigators.

About Skin Cancer in Australia

Australia has the highest rate of skin cancer in the world. Two out of three Australians will be diagnosed with some form of skin cancer before the age of 70. Basal cell carcinoma and squamous cell carcinoma are the most common types of non-melanoma skin cancer. In Australia, about 430,000 cases of basal cell and squamous cell carcinomas are diagnosed and treated each year.

About BLZ-100

BLZ-100 is the first product candidate developed from the Tumor Paint technology platform. Tumor Paint technology is designed to provide real-time, high-resolution intraoperative visualization of cancer cells, enabling better detection and more complete and precise surgical removal of cancer, and has potential applications in a broad array of solid tumor cancers. BLZ-100 is a combination of a targeting peptide, which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. BLZ-100 is under development for cancer surgery in multiple solid tumor types.

About Blaze Bioscience

Blaze Bioscience is dedicated to developing products that assist physicians in their quest to improve the lives of cancer patients. Blaze was co-founded by Dr. Jim Olson of Fred Hutchinson Cancer Research Center and Heather Franklin, a former senior business executive at ZymoGenetics, Inc., to develop and commercialize Tumor Paint technology. For additional information, please visit www.blazebioscience.com.

CONTACT

Rathbun Communications
Julie Rathbun, 206-769-9219
julie@rathbuncomm.com
or
Blaze
Bioscience, Inc.
Heather Franklin, CEO and President
Heather.Franklin@blazebioscience.com

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