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FDA Approves ImPact Biotech's Phase 1 Clinical Programme for Padeliporfin VTP in Lung Cancer

Saturday, August 05, 2023

ImPact Biotech has received clearance from the U.S. Food and Drug Administration for clinical investigation plan involving Padeliporfin Vascular Targeted Photodynamic (VTP) therapy. This therapy is intended for treating patients with Peripheral Lung Cancer.

The planned Phase 1/1b study is structured to evaluate the safety, feasibility, and optimal light dosage of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy and to show that the Padeliporfin VTP provides a safe and effective treatment enabling patients and doctors to have an extra therapy option to directly target the disease.

This comprehensive study will be conducted across multiple centres and will follow an open-label approach. The methodology involves employing Robotic Assisted Bronchoscopy and cone beam CT guidance to facilitate precise lung tumour ablation in individuals diagnosed with Peripheral Lung Cancer.

Padeliporfin VTP is a minimally invasive oncology platform designed to treat solid tumours. This approach combines surgical efficacy with the preservation of healthy tissue and organs. The therapy involves intravenously delivering an inactive drug, Padeliporfin, which is then activated by light.

When activated, the drug causes the blood supply in the illuminated area to constrict, leading to targeted tumour necrosis. This process also activates anti-tumour immunity, enhancing the eradication of cancer cells.      

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