First-in-Human Trial to Enroll Up to 24 Patients with Refractory Solid Tumors
Mountain View, Calif. – January 19, 2020 – BioEclipse Therapeutics™ (BioEclipse), a private clinical-stage biopharmaceutical company with a proprietary platform for developing next-generation cancer immunotherapies, announced today the initiation of patient enrollment at the HonorHealth Research Institute in Scottsdale, Ariz. for a Phase 1 dose-escalation trial to treat refractory solid tumors. The trial marks the first-in-human study of CRX100, an intravenously delivered agent designed to target and destroy multiple cancer types and address disease recurrence.
“We are excited to be working with HonorHealth as we advance CRX100 into the clinic, an event that marks a major milestone for our company,” stated Pamela Contag, Ph.D., President and CEO of BioEclipse. “CRX100 is a single therapeutic designed to attack multiple characteristics of numerous cancer types. With this new approach, BioEclipse is poised to address the substantial and growing unmet need for treatment options for solid tumors and metastatic disease considered by many to be untreatable.”
This open-label, Phase 1 dose-escalation study is to determine the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in up to 24 participants 18 years or older with advanced solid tumors that do not respond to standard of care. The trial specifically targets six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer. Each patient will receive up to two doses of CRX100. As secondary endpoints, the trial will also investigate the effect CRX100 has on a participant’s tumor progression and overall immune response.
More information about this study and general information about participating in clinical trials can be found at ClinicalTrials.gov.
BioEclipse is currently focused on the treatment of recurring cancers with a unique multi-mechanistic approach that could address cancers believed to be untreatable. Developed with technology exclusively licensed from Stanford University, CRX100 combines activated immune cells, known as cytokine-induced killer (CIK) cells, with an oncolytic virus. When the two components were combined in preclinical animal models, they worked together to attack the cancer.
“We are excited to begin working with BioEclipse to evaluate CRX100 for the first time in human study participants, given the urgent need for better cancer therapies, especially for patients with cancers that do not respond to standard treatments,” said Jasgit Sachdev, M.D., Director, Breast and Gynecological Early Phase Clinical Trials at HonorHealth Research Institute, and a Principal Investigator for this study. “Refractory disease is challenging to treat. Data from preclinical models assessing the treatment approached used by CRX100 suggest the potential to address several types of cancer and bring hope to patients with otherwise poor prognosis.”
About BioEclipse Therapeutics™
BioEclipse Therapeutics™ is an emerging, clinical-stage biopharmaceutical company using a novel platform that combines immune cells and an oncolytic virus to expand treatment options for patients with refractory solid tumors. Our focus is currently on treatment of recurring cancers with our unique multi-mechanistic approach that could address cancers believed to be untreatable. BioEclipse Therapeutics™ is preparing to initiate Phase 1 clinical trials with, CRX100, a patented, first in class, intravenously delivered, targeted immunotherapy against solid tumors. CRX100 is being developed to deliver potentially curative treatment to patients over a broad range of tumor types, including some rare pediatric cancers. For more information, visit www.bioeclipse.com.
HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 12,300 employees, 3,700 affiliated physicians and 3,100 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth’s mission is to improve the health and well-being of those we serve. Learn more at HonorHealth.com.
About HonorHealth Research Institute
HonorHealth Research Institute is helping shape the future of medicine by finding cures and improving treatments in area such as gene therapy, early drug/device development, early detection and prevention of disease. Through clinical trials and applied research, HonorHealth Research Institute e has given hope and improved the lives of patients from all 50 states and 28 different countries around the globe. HonorHealth Research Institute’s advanced technologies and cutting-edge treatment options are introducing tomorrow’s cures, today. For more information on oncology clinical trials call 480-323-1364, email firstname.lastname@example.org or learn more at HonorHealth.com/research. Follow HonorHealth Research Institute on Facebook, LinkedIn and Twitter.