ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administration cleared ImPact’s clinical investigation plan of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for the treatment of patients with Peripheral Lung Cancer.

The planned Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects, is designed as a multicenter, open-label study of Padeliporfin VTP using Robotic Assisted Bronchoscopy and cone beam CT guidance for lung tumor ablation in patients with Peripheral Lung Cancer.

Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Patients who are candidates for lung resection will be recruited as a diagnose-and-treat in the same anesthesia; surgery will be performed at least 5 days and up to 21 days following the VTP procedure.

Barak Palatchi, CEO of ImPact Biotech, said, “We are delighted to receive FDA clearance to proceed with our planned clinical program for Padeliporfin VTP in Lung Cancer, further validating ImPact’s technology and the potential benefits our product could bring to patients with Peripheral Lung Cancer. Our strategy, focusing Padeliporfin VTP therapy on patients with limited treatment options, is proceeding according to our ambitious plan, with NSCLC as one of its major pillars. We are planning to demonstrate that Padeliporfin VTP offers a safe and effective treatment that will provide patients and their physicians with an additional therapy platform to target the disease. We are looking forward to exploring the possibility of offering Padeliporfin VTP to more patients coping with life threatening cancers.”

ImPact Biotech is focusing on the development of Padeliporfin VTP as a minimally invasive oncology platform for the treatment of solid tumors, with the potential to offer surgery-like efficacy, combined with healthy-tissue or organ preservation in solid tumors for high-risk surgical patients with unmet needs – either because surgery is not the preferred clinical option, or the risk of surgery is too high.