Lumicell Announces FDA Approval To Launch Feasibility Study In Gastrointestinal Cancers

Trial is funded by National Cancer Institute’s SPORE program

WELLESLEY, Mass.--(BUSINESS WIRE)--Lumicell, a leader in the field of image-guided cancer surgery, has received approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study in gastrointestinal cancers. The study will focus on imaging tissue in patients with esophageal, colorectal and pancreatic cancers. The study will be conducted at Massachusetts General Hospital (MGH) and will be led by Dr. Charles S. Fuchs, MD, MPH, FACP, Director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute and Dr. Andrew T. Chan, MD, MPH, Program Director of Gastroenterology Training at MGH. Dr. Umar Mahmood, Associate Professor of Radiology, Harvard Medical School, will be a collaborator.

“The launch of a feasibility study in gastrointestinal cancers is an important next step for our company”

The National Cancer Institute’s (NCI) SPORE Program — the Specialized Programs of Research Excellence — is funding this clinical trial through the NCI Translational Research Program (TRP). TRP is home of the SPOREs, a cornerstone of NCI’s efforts to promote collaborative, interdisciplinary translational cancer research.

SPORE grants involve both basic and clinical/applied scientists and support projects that will result in new and diverse approaches to the prevention, early detection, diagnosis and treatment of human cancers. SPOREs in GI cancers focus on translational research in the gastrointestinal system which includes cancers of the colon, rectum, stomach, esophagus, small intestine, liver, gallbladder and other digestive organs.

“The launch of a feasibility study in gastrointestinal cancers is an important next step for our company,” said W. David Lee, CEO of Lumicell. “We are proud to partner with the Dana-Farber Cancer Institute and MGH to conduct this study. The SPORE grant will allow our team to test our imaging system in patients with esophageal, colorectal and pancreatic cancers. We will seek to demonstrate that our technology detects cancer as confirmed by pathology.”

According to the American Cancer Society, over 290,200 newly diagnosed cases of cancer in the digestive system, and 144,570 deaths, were expected in the United States in the year 2013. Colorectal cancer is the 3rd leading cause of cancer death and was expected to cause 50,830 deaths in the U.S. in 2013.

“NCI and the SPORE Program are both leaders in cancer research and their support of this study in gastrointestinal cancers is a critical step in moving this technology forward,” said Dr. Charles S. Fuchs, MD, MPH, FACP, Director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute. “Our study includes three surgical oncologists from both Dana Farber/Brigham and Women’s Cancer Center and MGH. I truly look forward to working with this team toward the goal of demonstrating the effectiveness of this surgical system.”

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. Lumicell’s intraoperative detection system provides surgeons with the needed tools to perform a thorough removal of any residual cancer cells in real-time within the tumor bed thus eliminating the need for repeat surgeries due to positive margins or local recurrence.

Lumicell’s surgical system combines a lightweight hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent. This image-guided technology is designed to fit within the existing surgical workflow. The company’s devices and imaging agents are optimized for the specific cancer-type and surgical procedure.

About Dana-Farber Cancer Institute

Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School, is world-renowned for its leadership in adult and pediatric cancer treatment and research. Designated as a comprehensive cancer center by the National Cancer Institute (NCI), it is one of the largest recipients among independent hospitals of NCI and National Institutes of Health grant funding. For more information, go to www.dana-farber.org.

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.