Lumicell Presents Phase 2 Clinical Data Showing LUM System Provided Complete and Immediate Detection of Residual Cancer in Tumor Cavity During Lumpectomy Surgery

Data Presented by Investigators from Massachusetts General Hospital's Breast Program at 2017 San Antonio Breast Cancer Symposium

Integrated LUM System Correctly Identified Residual Cancer Cells Across Breast Cancer Subtypes

WELLESLEY, Mass.--()--Lumicell, Inc. today announced the presentation of clinical data from its ongoing Phase 2 breast cancer trial with the LUM System, which integrates the immuno- and cancer-targeted optical agent LUM015, the Lumicell handheld imaging device and decision software to detect cancer cells in real-time during surgery. The Phase 2 data demonstrated that the integrated LUM System provided complete and instantaneous detection of residual cancer in tumor cavity and the ability to detect all breast cancer sub-types including invasive ductal cancer (IDC), invasive lobular cancer (ILC) and ductal carcinoma in situ (DCIS) during lumpectomy surgery. In addition, the LUM System correctly identified residual cancer (positive margins) within the tumor cavity in all patients studied, as confirmed by standard histopathology. The Phase 2 data were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) being held December 5-9, 2017 in San Antonio, Texas.

“By providing instantaneous identification of residual tumor in the lumpectomy cavity, the LUM System has the potential to provide surgeons with enhanced information to improve care for their breast cancer patients.”

“Our goal with the LUM System is to provide surgeons with immediate cancer cell detection, thereby reducing the need for second surgeries,” said Kelly Londy, Chief Executive Officer of Lumicell. “The data presented at San Antonio further supports our advancement into pivotal breast cancer studies and continued clinical expansion into other solid tumor cancers including prostate cancer, colorectal, esophageal and pancreatic cancers, among others.”

"Currently, up to 40% of breast cancer lumpectomy patients have positive margins that require surgical re-excision,” said Barbara L. Smith, MD, PhD. Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School. “By providing instantaneous identification of residual tumor in the lumpectomy cavity, the LUM System has the potential to provide surgeons with enhanced information to improve care for their breast cancer patients.”

In a poster presentation titled, “Real-time, intraoperative detection of residual breast cancer in lumpectomy cavity margins using the LUM Imaging System: Results of a feasibility study,” Lumicell collaborators at Massachusetts General Hospital’s Breast Program presented data from the Phase 2 clinical study in which tumor cavity walls of patients (N= 45) undergoing breast cancer lumpectomy were assessed intraoperatively using the LUM System. LUM015, a cathepsin-activatable fluorescent agent, was administered intravenously approximately four hours prior to surgery. Areas of fluorescence generated at potential sites of residual tumor in lumpectomy cavities were evaluated with a sterile hand-held device, displayed on a monitor, excised and correlated with histopathology. The data showed:

  • The LUM System showed 100% sensitivity and 73% specificity for detection of tumor ≤2mm from the margin.
  • Invasive ductal, invasive lobular and areas of ductal carcinoma in situ as small as 1mm in size were identified using the LUM System.
  • There were no serious adverse events reported during the study.

“The LUM System continues to be well-tolerated during breast cancer surgeries, and importantly, all residual cancer cells in the tumor cavity were correctly identified,” said Felix Geissler MD, PhD, Chief Medical Officer of Lumicell. “Additional studies are underway to continue to validate and optimize the LUM System in this setting.”

About the LUM System
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. 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.

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 company’s LUM System has unprecedented ability to see and remove cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and 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.

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