World’s 1st Patient Enrolled in International FDA Approved Phase III RCT of Breast Cancer Surgery

750 516 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) announced it has enrolled the first patient in its Pivotal Phase III randomized controlled trial evaluating the safety and efficacy of PD G 506 A (5-ALA HCl) in margin assessment during breast conserving surgery, after receiving FDA IND clearance for the trial in April. Detailed information can be found here.

These achievements mark important steps in SBI Canada’s ongoing clinical investigations into the use of 5-ALA’s tumor selectivity and the novel fully handheld Eagle imaging technology for improved intraoperative margin assessment and fluorescence-guided surgery for breast cancer and ultimately other cancers where real-time intraoperative carcinoma visualization is a clinical priority. Phase II results led by the DaCosta lab and clinicians at PMCC laid the foundation for the Phase III RCT and the patented Eagle fluorescence imaging technology was invented and developed in the DaCosta lab.