ImPact Biotech has received FDA clearance for the Phase 1 Clinical Program of Padeliporfin VTP in Peripheral Lung Cancer

Saturday, August 05, 2023

ImPact Biotech, renowned for its expertise in IMmune Photo Activated Cancer Treatment (IMPACT), has recently obtained FDA clearance for its clinical investigation plan featuring Padeliporfin Vascular Targeted Photodynamic (VTP) therapy. The objective of this plan is to provide treatment for patients diagnosed with Peripheral Lung Cancer.

The Phase 1/1b study is designed to evaluate the safety, feasibility, and light dose titration of Padeliporfin VTP. This multicenter, open-label trial will utilize Robotic Assisted Bronchoscopy and cone beam CT guidance to assess the therapeutic ablation effects in patients with Peripheral Lung Cancer.

The study will enroll patients at a high risk of peripheral primary lung cancer, particularly those in stage 1A1/1A2, who are eligible for surgical treatment. Following the VTP procedure, lung resection will be performed between 5 to 21 days under the same anesthesia.

Barak Palatchi, CEO of ImPact Biotech, expressed great enthusiasm regarding the FDA clearance and highlighted their dedication to advancing Padeliporfin VTP technology for the benefit of patients with limited treatment options, especially those with Peripheral Lung Cancer. The company's goal is to demonstrate that Padeliporfin VTP provides a safe and effective treatment, offering patients and physicians an additional therapy platform to effectively target the disease.

ImPact Biotech's primary focus lies in developing Padeliporfin VTP as a minimally invasive oncology platform for treating solid tumors. The therapy aims to deliver surgical-like efficacy while preserving healthy tissue and organs in high-risk surgical patients with unmet needs, either due to the preference against surgery or the increased risks associated with surgical intervention.

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