Phase 1 Results Also Presented at AACR 2015 Annual Meeting
Wellesley, Mass., May 8, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, announced that Phase 1 trial results were recently presented at the SSO 2015 Annual Cancer Symposium in March and the AACR 2015 Annual Meeting in April. Both sessions were presented by Lumicell’s clinical collaborators at Duke University Medical Center.
Lumicell recently completed its Phase 1 safety study at Duke University Medical Center in the lead indications of breast cancer and sarcoma. The Phase 1 study of Lumicell’s leading imaging agent was completed with cancer patients under-going surgery. No imaging agent related adverse events were reported during the study, indicating the safety of Lumicell’s imaging agent.
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. Imaging results from the Phase 1 safety study demonstrate that Lumicell’s imaging agent provides excellent contrast between normal tissue and a tumor.
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. The US Patent Office has allowed broad patent claims on both the device and the imaging agent which will provide excellent IP protection.
Lumicell has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study for intraoperative imaging of breast cancer during surgery. The study will be conducted at Massachusetts General Hospital (MGH). Further trial information can be found here: https://clinicaltrials.gov/show/NCT02438358.
The Principal Investigator for the feasibility study is Dr. Barbara Smith, Director, Breast Cancer Program and Co-Director, Gillette Center for Women’s Cancer at MGH.
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.
