Canadian pharmaceutical company Theralase Technologies has released interim clinical data from its Phase II study of its intravesical photodynamic therapy Ruvidar (TLD-1433) to treat patients with non-muscle invasive bladder cancer.
The open-label, multi-centre study (NCT03945162) has treated 63 patients to date. According to the interim clinical data, the primary endpoint of complete response (CR) has been met by 54% of patients at six months, 38% at 12 months and 37% at 15 months.
For patients who received optimised treatment post 1 August 2020, 62% of patients had a CR at 90 days. Over 80% of patients remained in the study after 90 days.
Theralase was awarded fast track designation from the US Food and Drug Administration (FDA) in 2020 for TLD-1433 in this indication.
The company submitted a pre-breakthrough therapy designation (BTD) last year, with the FDA providing feedback on clinical study sites and a regulatory consulting organisation to update the pre-BTD with clarifications on the clinical data identified by the FDA. As per the press release, Theralase will resubmit the pre-BTD to the FDA in Q1 2024.
This study builds on the Phase I clinical trial (NCT03053635) which evaluated the safety, efficacy, tolerability, and pharmacokinetics of a Ruvidar infusion and photodynamic therapy. The company reported that it had achieved the exploratory endpoint of efficacy in patients with non-muscle invasive bladder cancer back in 2017.
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Ruvidar binds to transferrin on cancer cells, with the bound TLD-1433 released into the cells. Light activation using laser technology leads the production of reactive oxygen species and singlet oxygen that are toxic to cells. The drug candidate is administered through intravesical and parenteral route.
According to GlobalData’s Pharma Intelligence Center, Ruvidar is forecast to generate $118m in sales in 2029.
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