Pivotal trial expected to begin by end of 2019 for the Lumicell Imaging System for intraoperative detection and removal of residual cancer in breast-conserving surgery.
NEWTON, Mass.–(BUSINESS WIRE)–#cancer–Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced that it has completed enrollment in its Phase C feasibility clinical trial of the Lumicell Imaging System for breast cancer. With results from the Phase C feasibility trial expected in late 2019, Lumicell expects to begin the pivotal trial by the end of 2019 before applying for FDA approval.
Breast-conserving surgery is a critical first step of treatment for many women with breast cancer. The goal is to remove all the cancer cells, leaving behind only healthy tissue. However, today, surgeons do not have adequate tools to determine if all cancer has been removed during the initial surgery; instead, patients must wait until days after surgery to find out if all the cancer has been removed. Unfortunately, in as many as 20-40% of cases, cancer cells are found at the margins of the removed tissue, typically requiring patients to undergo a second surgery to remove the remaining cancer.
Lumicell has developed a novel system intended to enable surgeons to see and remove residual cancer cells in real-time during the initial surgery, with the ultimate goal of reducing the risk of second surgeries and cancer recurrence, while also minimizing healthy tissue removal and improving efficiency in the operating room.
“My goal is to provide the best outcomes for patients under our care at Novant Health. One of the most important ways we do that is through innovative technology. The Lumicell System gives me increased confidence during my lumpectomy procedures; for numerous patients enrolled in the Phase C trial, my team was able to avoid a second surgery by identifying and removing tissue highlighted by the Lumicell System. I’m encouraged by our experiences with the system thus far, and I’m eager to have this as an option available for all of our breast cancer patients,” said Dr. David Carr, MD, General Surgeon at Novant Health Salem Surgical Associates and principal investigator for the Lumicell breast cancer trial at Novant Health.
The Lumicell Phase C trial is a multi-center, prospective clinical study of 234 patients across 16 sites, comprised of both academic medical centers and community hospitals. Dr. Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, is the lead investigator of the Lumicell breast cancer trials. Findings from this trial — the third feasibility study of the Lumicell System for Breast Cancer — will be published at the end of 2019. Lumicell is also expecting to initiate the pivotal trial stage later this year to support an FDA submission for approval of the Lumicell System for the treatment of breast cancer.
“With the Lumicell Phase C trial now fully enrolled, we are quickly moving forward with the data review, and finalizing the design and plans for the pivotal study to begin later this year,” said Andrey Zarur, PhD, Executive Chairman at Lumicell. “We’re confident that we have developed a pivotal trial design that is compelling to patients and surgeons. And we’re optimistic that the pivotal trial will deliver results clearly demonstrating the clinical value of the Lumicell System in the treatment of breast cancer and benefits to the patients.”
The Lumicell System is also in early feasibility trials for treatment of prostate, brain, colorectal, esophageal and pancreatic cancers, as well as peritoneal metastases from primary ovarian and colon cancers.
For more information about Lumicell’s clinical trials, visit http://www.lumicell.com/clinical-trials/clinical-trials.php.
About Lumicell, Inc.
Lumicell illuminates cancer and other diseased tissues at the molecular level, enabling physicians to take action in real time during surgeries to improve patient outcomes. Lumicell technology features an investigational onco-fluorescent agent, handheld device and software to help cancer surgeons identify and remove cancer cells. The technology — designed and developed through collaboration with MIT engineers and leading breast cancer surgeons — fits seamlessly into existing surgical workflow. Lumicell is investigating the Lumicell Imaging System in patients undergoing surgery for breast, ovarian, prostate, colorectal, esophageal, pancreatic, and brain cancers, as well as peritoneal metastases. For more information, please visit www.lumicell.com.
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