ImPact Biotech receives FDA Clearance for Padeliporfin VTP Phase 1 Clinical Program in Peripheral Lung Cancer

  • Padeliporfin VTP Phase 1 trial in Peripheral Non-Small Cell Lung Cancer to start by end Q4 2023

TEL AVIV, Israel, Aug. 04, 2023 (GLOBE NEWSWIRE) --  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.

About Padeliporfin VTP

Padeliporfin VTP (Vascular Targeted Photodynamic) therapy is a minimally invasive oncology platform for the treatment of solid tumors. It offers surgery-like efficacy combined with healthy-tissue or organ preservation. VTP comprises the intravenous delivery of an inactive drug, Padeliporfin. Upon light activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which in-turn enhances cancer cell eradication.        

About ImPact Biotech

ImPact Biotech is an Israeli biotech organization with operations in the EU, Israel and the US. ImPact biotech focuses on the development of a minimally invasive novel oncology platform to treat a range of solid tumors with Padeliporfin VTP (Vascular Targeted Photodynamic) therapy. ImPact Biotech is implementing a bold strategy concentrating on a range of solid tumors with a high medical need such as UTUC, NSCLC and Pancreatic cancer.

ImPact Biotech’s strong relationships with The Weizmann Institute of Science in Israel and Memorial Sloan Kettering Cancer Center in the US have produced exciting early results in a range of solid tumor types, including UTUC, Esophageal, Lung and Pancreatic Cancer. These programs are now being accelerated into the clinic, supported by the safety and efficacy profile already established during earlier research in low-risk prostate cancer.

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