Fluorescence-Guided Breast Cancer Surgery: International Pivotal Phase III RCT receives FDA IND Clearance

1030 579 DaCosta Lab

Today, SBI ALApharma Canada Inc., a subsidiary of photonamic GmbH & Co. KG ( Pinneberg, Germany), a subsidiary of SBI Holdings, Inc. (Minato-ku, Tokyo); received FDA Investigational New Drug (IND) clearance for its Pivotal Phase III randomized controlled trial (RCT) evaluating the safety and efficacy of PD G 506 A (5-ALA HCl) in intraoperative margin assessment during breast conserving surgery. This multicenter trial involves over 400 patients across 20 centers across the US and Canada and will use SBI Canada’s patented intraoperative handheld Eagle Fluorescence Imaging SystemTM to visualize 5-ALA-induced protoporphyrin IX (PpIX) fluorescence in real-time in breast cancer tissues during surgery.

An earlier Phase II clinical study at Princess Margaret Cancer Center demonstrated that 5-ALA–induced PpIX fluorescence in otherwise clinically occult carcinoma can be visualized in surgical specimens and within the surgical cavity in real-time using the handheld camera of the Eagle device. Through this Phase III trial, the Eagle imaging device will enable surgeons to examine the surgical cavity following lumpectomy to identify residual disease  for surgical resection during the index procedure. The Eagle imaging technology was originally invented and developed in the DaCosta lab at the Princess Margaret cancer Center before being licensed to photonamic GmbH & Co. KG in 2019.

FDA IND approval of this Phase III RCT marks a major milestone after a decade long journey initiated and led by the DaCosta lab through the earlier Phase II trial at PMCC with surgeons Drs. Wey Leong and Alexandra Easson and pathologist Dr. Susan Done. The long term goal of the Phase III RCT is to reduce the otherwise suboptimal re-excision rate for patients undergoing breast conserving surgery globally.