FDA authorises Lumicell to launch feasibility study in breast cancer

21 May 2015 (Last Updated May 21st, 2015 18:30)

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Lumicell to initiate a feasibility study for intraoperative imaging of breast cancer during surgery.

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Lumicell to initiate a feasibility study for intraoperative imaging of breast cancer during surgery.

Lumicell will conduct a pilot study with its imaging agent, LUM015, at Massachusetts General Hospital (MGH).

The National Cancer Institute (NCI) funded pre-clinical toxicology tests and the production of an imaging agent for feasibility clinical trials through the NCI Experimental Therapeutics (NExT) programme.

NCI awarded additional funding to the company and MGH's Breast Cancer Programme Director from an R21 Early Phase Trials programme to support the feasibility study in breast cancer.

"Lumicell will conduct a pilot study with its imaging agent, LUM015, at Massachusetts General Hospital (MGH)."

Lumicell CEO David Lee said: "Launching a feasibility study for intraoperative imaging of breast cancer during surgery is a critical next step for Lumicell.

"The NCI grant allows our team to demonstrate the efficacy of our system in reducing rates of positive margins and repeat surgeries.

"By enabling surgeons to remove sub-millimetre residual cancer, we expect to improve patient outcomes."

The company completed a Phase I safety study with LUM015 at Duke University Medical Centre in the indications of breast cancer and sarcoma without finding any agent-related adverse events.

The LUM015 intraoperative detection system offers surgeons the tools required to perform a thorough removal of any residual cancer cells in real-time within the tumour bed, eliminating the need for repeat surgeries due to positive margins or local recurrence.

Combing a lightweight hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent, the system is designed to fit within the existing surgical workflow.

Lumicell's devices and imaging agents are said to be optimised for the specific cancer type and surgical procedure.