US-based biopharmaceutical firm Heat Biologics has dosed the ninth and final patient required in the Phase I portion of its Phase I/II clinical trial of Vesigenurtacel-L (HS-410), to treat patients with high-risk non-muscle invasive bladder cancer.
Recently, the company modified the Phase I/II Vesigenurtacel-L trial treatment regimen to include a more robust dose-response analysis and the expedited advancement into Phase II trials following completed enrolment of a single group of Phase I data.
The multi-centre Phase I/II trial will enrol around 84 patients with non-muscle invasive bladder cancer and is designed to determine whether vaccination with Vesigenurtacel-L, after transurethral resection of bladder tumour (TURBT), extends the time to disease recurrence compared to placebo.
Safety and immune response of Vesigenurtacel-L in bladder cancer patients will also be evaluated in this trial.
Heat Clinical and Regulatory Affairs vice-president Melissa Price said: "I am pleased we have met our study timeline objectives for the Phase I dosing to enable us to advance to Phase II.
"Most importantly, there have been no reported serious adverse events related to our vaccine. We are on track to begin Phase II a full quarter sooner that originally reported."
The company intends to begin the Phase II portion of the bladder cancer trial during the fourth quarter of 2014. Patient enrolment and dosing in this portion of the trial is expected to be completed in the third quarter of 2015.
Heat chief executive officer Jeff Wolf said: "Heat’s clinical team and principal investigators are now in a position to quickly progress Vesigenurtacel-L into Phase II enrolment.
"The initiation of the Phase II dosing will provide Heat and its stakeholders with much awaited key data on top-line recurrence-free survival for our ImPACT bladder cancer vaccine even earlier than we anticipated.
"We believe this accelerated timeline has the potential to benefit high-risk patients with non-muscle invasive bladder cancer and brings us one step closer to providing a much needed viable treatment option."
The company intends to reporting top-line recurrence-free survival results from the Vesigenurtacel-L Phase II trial in the third quarter of 2016 after the protocol’s twelve-month patient observation period ends.
