Israel-headquartered ImPact Bio expects to submit an investigational new drug application (IND) later in 2023, with a Phase I trial of the treatment in patients with locally advanced pancreatic ductal adenocarcinoma also scheduled for this year, per a 5 July press release.
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Orphan drug designations come with certain benefits such as granting tax credits for US-based clinical trials and recommendations from the FDA on the required clinical and preclinical studies.
Padeliporfin VTP is based on the combined use of the drug padeliporfin and non-thermal laser light. The drug is administered intravenously to a patient after which it is activated by a non-thermal laser light in the specific area of the tumour, per the company’s website. The light results in the drug’s rapid response in the illuminated area, constricting blood supply and tumour necrosis. The approach used in the therapy was initially developed at the Weizmann Institute of Science.
Notably, the European Commission authorised the therapy, marketed under the name Tookad, for use in men with low-risk prostate cancer in November 2017. However, in February 2020, an FDA Advisory Committee (AdCom) voted mainly against the treatment’s use in prostate cancer in the US.
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