On October 2, 2014 Heat Biologics reported that it has dosed the ninth and final patient required in the Phase 1 portion of its Phase 1/2 clinical study for Vesigenurtacel-L (HS-410) in patients with high-risk non-muscle invasive bladder cancer (Filing 8-K , Heat Biologics, OCT 2, 2014, View Source [SID:1234500780]). The Company expects to commence the Phase 2 portion of the bladder cancer clinical trial during the fourth quarter of 2014.

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Melissa Price, Ph.D., Heat’s Vice President of Clinical and Regulatory Affairs commented, "I am pleased we have met our study timeline objectives for the Phase 1 dosing to enable us to advance to Phase 2. Most importantly, there have been no reported serious adverse events related to our vaccine. We are on track to begin Phase 2 a full quarter sooner that originally reported."

Heat recently modified the Phase 1/2 Vesigenurtacel-L study treatment regimen to include a more robust dose-response analysis and the expedited advancement into Phase 2 trials following completed enrollment of a single cohort of Phase 1 data.

"Heat’s clinical team and principal investigators are now in a position to quickly progress Vesigenurtacel-L into Phase 2 enrollment," said Jeff Wolf, Chief Executive Officer. "The initiation of the Phase 2 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."

Patient enrollment and dosing in the Vesigenurtacel-L Phase 2 study for the treatment of bladder cancer is expected to be completed in the third quarter of 2015. Heat then anticipates reporting top-line recurrence-free survival results in the third quarter of 2016 after the protocol’s twelve-month patient observation period ends.

For patients and physicians interested in enrollment information for the Phase 2 portion of the study of Vesigenurtacel-L in patients with high-risk non-muscle invasive bladder cancer, please visit clinicaltrials.gov and use Identifier NCT02010203.