Blaze Bioscience Inc. Commences Clinical Trial Of BLZ-100 In Patients With Sarcoma Undergoing Surgery

Study is the fifth Phase 1 clinical trial of BLZ-100 in Blaze’s solid tumor program

SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company^®, a biotechnology company focused on guided cancer therapy, today announced open enrollment for a clinical study of Tumor Paint BLZ-100 in soft tissue sarcoma. The study, titled “A Phase 1 study of BLZ-100 administered by intravenous injection in subjects with soft tissue sarcoma undergoing surgery,” is supported by a Small Business Innovation Research (SBIR) Phase II contract awarded to the company by the National Cancer Institute (NCI)¹ following the successful completion of a Phase I SBIR contract. This is the fourth Phase 1 clinical trial under the company’s open Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). The study will be conducted at Cedars-Sinai Medical Center in Los Angeles under the direction of Principal Investigator Charles Forscher, M.D., and will enroll up to twenty-one (21) patients.

“This clinical study of BLZ-100 will add to our growing understanding of the potential broad utility of BLZ-100 in cancer surgery and provide further insight to the timing of BLZ-100 dosing relative to tumor surgery.”

Further information on the study can be found at www.clinicaltrials.gov.

Soft tissue sarcoma is a rare disease with a high unmet need and, according to NCI, approximately 11,900 new cases of soft tissue sarcoma will be diagnosed in 2015 in the U.S. Surgery remains the principle mode of therapy for soft tissue sarcoma, and successful surgery—achieving complete resection with negative tumor margins—reduces the chance of recurrence and the need for more treatment, such as radiation or repeat surgery. “Sarcoma is an often aggressive cancer that disproportionally affects children and young adults. Improvements to treatment, including surgical intervention, are greatly needed,” said Dennis Miller, Ph.D., Blaze Bioscience’s Senior Vice President of Development and Principal Investigator on the NCI contract. “This clinical study of BLZ-100 will add to our growing understanding of the potential broad utility of BLZ-100 in cancer surgery and provide further insight to the timing of BLZ-100 dosing relative to tumor surgery.”

“Our goal with Tumor Paint BLZ-100 is to provide surgeons with the ability to see cancer at high resolution throughout surgery to improve rates of complete resection and negative margins,” said Blaze Bioscience co-founder and CEO Heather Franklin. “We continue our pursuit to improve cancer surgery and help millions of patients in their fight against cancers. Our broad clinical program studying BLZ-100 in skin, brain, lung, prostate, breast, colorectal cancer, and sarcoma will continue to inform our plans for late-stage clinical studies which are anticipated to begin in 2016.”

About BLZ-100

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 of Tumor Paint technology has been demonstrated in a wide range of cancer types. BLZ-100 is currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumor cancers.

About Blaze Bioscience

Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. 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 member of the executive management team at ZymoGenetics. Blaze is working to develop Tumor Paint products and Optide-based 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. In addition to the Tumor Paint platform, Blaze is collaborating with the Fred Hutchinson Cancer Research Center to discover and develop products based on knottin peptides as part of the Optides platform. This program extends the expertise gained in developing the Tumor Paint platform to optimized knottin peptides for therapeutic and imaging applications. For additional information, please visit www.blazebioscience.com.

¹ $1.5 million of the program will be financed with federal funds from National Cancer Institute, National Institutes of Health under Contract No. HHSN261201400046C. An estimated twenty-nine percent (29%) of costs will be funded by the Company.