Revolutionary Approach to Imaging Tumor Cells Demonstrated to be Well Tolerated in First Patient Samples
Wellesley, Mass., January 6, 2016 – Lumicell, a leader in the field of image-guided cancer surgery, today announced the publication of research supporting the Company’s groundbreaking protease-activated fluorescent imaging probe, LUM015, in Science Translational Medicine. The research highlights the use of LUM015 to detect cancer in vivo in a mouse model of soft tissue sarcoma (STS) and ex vivo in a first-in-human Phase I clinical trial (NCT01626066). In the research article entitled “A Mouse-Human Phase I Co-Clinical Trial of a Protease-Activated Fluorescent Probe for Imaging Cancer,” the authors highlight how the first-in-human Phase I trial showed tumor-specific fluorescence to be safe and well tolerated in humans.
Lumicell is addressing the number one challenge in cancer surgery – the need to remove all cancer cells within the tumor bed during the first surgery. In the field of cancer surgery, the goal is clean margins. Local recurrence is a common cause of treatment failure for patients with solid tumors. Intraoperative detection of microscopic residual cancer in the tumor bed could be used to decrease the risk of a positive surgical margin and could reduce rates of re-excision. The research published in Science Translational Medicine is the first study to use these probes to image human cancers.
Consistent with data from preclinical studies, when patients with STS or breast cancer were injected with LUM015 prior to surgery, the investigators found tumor tissue fluorescence measured ex vivo to be significantly higher than fluorescence measured from adjacent normal tissues. Furthermore, the study results show that the contrast between tumor and normal tissue is achieved with administration of LUM015 just a few hours before the surgery with no impact to the pre-operative workflow. Based on these results, Lumicell is currently conducting a clinical trial in breast cancer patients to compare in vivo intraoperative imaging of the tumor bed using Lumicell’s proprietary hand-held imaging device with surgical margin histopathology (NCT02438358). The imaging device has resolution capable of detecting microscopic cancer clusters as small as 100 cells in size.
“Given the very real unmet need for real-time detection of the presence of microscopic residual cancer within a tumor bed during surgery, we are pleased with this first-in-human trial and its demonstration of safety and tolerability,” said Dr. David Kirsch, Lead Investigator and Associate Professor of Radiation Oncology, Duke University Medical Center.
“As we strive to give surgeons real-time visual feedback of residual cancer in the tumor bed, our team is bolstered by our first-in-human study results,” said W. David Lee, CEO of Lumicell. “We are proud to partner with Duke University Medical Center and look forward to our continued collaborations as we drive toward the same goals in the field of image-guided cancer surgery.”
Study authors included M. J. Whitley1,2, D. M. Cardona3, A. L. Lazarides4, I. Spasojevic5,6, J. M. Ferrer7, J. Cahill8, C.L. Lee8, M. Snuderl9, D.G. Blazer III10, S. E. Hwang10, R. A. Greenup10, P. J. Mosca10, J. K. Mito1,2, K. C. Cuneo8, N. A. Larrier8, E. K. O’Reilly11, R. F. Riedel5, W. C. Eward12, D. B. Strasfeld7, D. Fukumura9, R. K. Jain9, W. D. Lee7, L. G. Griffith13, M. G. Bawendi14, D. G. Kirsch1,8 and B. E. Brigman12.
1Department of Pharmacology and Cancer Biology, Duke University Medical Center
2Medical Science Training Program, Duke University Medical Center
3Department of Pathology, Duke University Medical Center
4School of Medicine, Duke University Medical Center
5Department of Medicine, Duke University Medical Center
6PK/PD Core Laboratory, Duke Cancer Institute, Duke University Medical Center
7Lumicell Inc.
8Department of Radiation Oncology, Duke University Medical Center
9Edwin L. Steele Laboratory, Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School
10Department of Surgery, Duke University Medical Center
11Duke Translational Medicine Institute, Regulatory Affairs Group, Duke University Medical Center
12Department of Orthopaedic Surgery, Duke University Medical Center
13Department of Biological Engineering, Massachusetts Institute of Technology
14Department of Chemistry, Massachusetts Institute of Technology
About Lumicell, Inc.
Lumicell is a leader in the field of image-guided cancer surgery. The company is developing a revolutionary intraoperative imaging system that gives surgeons real-time visual feedback of residual cancer in the tumor bed. Lumicell’s surgical system includes a margin-targeted injectable imaging agent and a novel hand-held imaging device with exquisite single-cell detection. The unprecedented ability to see and remove all cancer cells during the initial surgery has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is initially investigating its imaging system in patients undergoing surgery for breast cancer and sarcomas. Additional future indications will include surgeries for lung, prostate, ovarian, colorectal and brain cancers. For more information, please visit www.lumicell.com.
Special Notes to Reporters
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