R01 Award to fund multi-phase randomized study to expand clinical safety and efficacy data of the system in the detection of residual tumor in breast cancer patients receiving neoadjuvant therapies
Newton, Mass., Sept. 29, 2020 – Lumicell, Inc. today announced that Dr. Barbara Smith, Director of the Breast Program at Massachusetts General Hospital, has begun a multi-phase, randomized clinical study utilizing the LUM Imaging System to obtain additional safety and efficacy data in breast cancer supported by an R01 award from the National Cancer Institute. The study follows compelling results from a multi-center Feasibility Phase C trial and runs concurrently with Lumicell’s pivotal trial. The study, led by Barbara Smith, is a collaboration with investigators Dr. Shelley Hwang at Duke, Dr. Irene Wapnir at Stanford, Dr. Anees Chagpar at Yale, and Dr. Kelly Hunt at MD Anderson and with Lumicell.
“This new NCI academic-industry clinical study will enroll approximately 400 patients, including an arm consisting of patients receiving neoadjuvant therapy. The study also focuses on collecting data as the first step to investigate the potential long-term impact of the LUM Imaging System in breast cancer treatment.
“Over the last decade, neoadjuvant therapies have become more prevalent as a standard treatment for breast-conserving surgeries. While there have been studies on the effectiveness of neoadjuvant therapies alone, we’re eager to study long-term outcomes of patients who also have the benefit of using in-vivo imaging to find residual cancer,” said Dr. Smith. “We’re encouraged by the data shown in the Phase C trial – and this next study supplements the ongoing pivotal study as an important piece in improving patient care and furthering innovations in breast cancer treatment.”
The LUM Imaging System was developed to enable surgeons to see and remove residual cancer in real time during the initial surgery. It is designed to reduce the risk of second surgeries and cancer recurrence while minimizing healthy tissue removal. This new study follows compelling clinical results from Lumicell’s 234-patient, 16-site Feasibility Phase C study that demonstrated the detection and removal of residual cancer, for both invasive cancers and ductal carcinoma in situ (DCIS), in 11% of patients after standard of care lumpectomy. Data from the Phase C study and the ongoing pivotal study will be used to support an application to the FDA for market approval for the LUM Imaging System.
“We are very excited to collaborate with Dr. Smith and this prestigious group of investigators on this important trial and look forward to evaluating the potential for improved treatment in breast cancer care by using the LUM Imaging System,” said Kevin Hershberger, CEO of Lumicell. “Our focus in developing the Lumicell System has been to improve patient outcomes by guiding the removal of residual cancer during initial surgeries and we are thrilled to extend this to patients receiving neoadjuvant therapies.”
For more information about Lumicell’s clinical trials, visit https://lumicell.com/clinical-trials/clinical-trials.php.
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 Lumicell System has unprecedented ability to see and guide removal of 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 Lumicell System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver cancers. For more information, please visit www.lumicell.com.
