Company receives FDA Approval to initiate multiple IDE studies, Including Path to Pivotal Trial in Breast Cancer
Integrated LUM System with Drug, Device and Software Currently Under Investigation in Five Solid Tumor Cancers
Wellesley, Mass., Sept. 6, 2017— Lumicell, Inc., a technology leader in the field of image-guided cancer surgery, today announced the initiation of clinical studies in breast cancer and prostate cancer with its LUM System. The initiation of the clinical trials is based on approval of Investigational Device Exemption (IDE) applications by the U.S. Food and Drug Administration (FDA) to enable the LUM System to be used in breast cancer and prostate cancer studies. The newly-initiated breast cancer study builds on previous clinical trials in breast cancer patients with the LUM System, and is a pivotal study in breast cancer following an initial training period with surgeons. The prostate cancer study will be the first clinical trial with prostate cancer patients.
The LUM System was designed by leading engineers and scientists in partnership with surgeons from academic and medical centers as an integrated system with three unified components: drug, device and decision software to guide cancer surgeons in the detection and removal of cancer cells in real-time during surgery. With the initiation of these two studies, the LUM System is now being clinically evaluated in five solid tumor indications, including colorectal, esophageal and pancreatic cancer.
“We are excited to initiate these new studies with the LUM System, which we have designed to detect and illuminate tumor cells at the invasive front of the tumor micro-environment where macrophages and other immune cells interact with cancer cells,” said Felix Geissler MD, PhD, Chief Medical Officer of Lumicell. “By enabling surgeons to clearly see cancer cells in real time during surgery, we have the opportunity to avoid leaving cancer cells behind and reduce the need for repeat surgeries. We look forward to providing further clinical updates on our progress with the LUM System later this year.”
“We are moving our clinical program forward with strong momentum, as the LUM System is now being clinically evaluated in five cancer indications in more than 10 medical centers across the U.S.,” said Kelly Londy, Chief Executive Officer of Lumicell. “We aim to set a new standard with our system in the field of image-guided cancer surgery, providing surgeons at any cancer facility with immediate visual feedback to detect tumor tissue beyond the margin of the specimen and opening up the potential to improve surgical outcomes for a broad range of cancer patients.”
The initiation of these studies is based on encouraging clinical feasibility data presented at the 2016 American Society of Breast Cancer Surgeons Meeting in which the LUM System achieved 100% detection of residual cancer, including invasive ductal, lobular and DCIS lesions (n=15), as confirmed by histopathology examination. Additional clinical data in breast cancer is expected to be reported at an upcoming medical meeting.
About Lumicell, Inc.
Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The LUM System includes three integrated components: a fluorescent optical contrast agent that is cancer- and immuno-activated, a novel hand-held imaging device that instantly scans the cavity walls to view the fluorescent cells with single-cell detection, and proprietary decision software that displays the image instantly on a monitor to guide surgical removal of cancerous tissue. The unprecedented ability to see and remove cancer cells remaining in the cavity – beyond the margin of the specimen – 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 investigating the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancers. For more information, please visit www.lumicell.com.