Boston, MA 10/03/2014 (wallstreetpr) – Heat Biologics Inc (NASDAQ:HTBX) said that it had completed the enrollment process of Phase 1 clinical trial studies of Vesigenurtacel-L. It has given the treatment to nine patients in the clinical trials. The trial is meant for testing the medication for treating Bladder Cancer. With the completion of Phase 1 trial, the focus shifts on initiation of Phase 2 trial that is expected to commence in the fourth quarter of 2014.
Phase 2 Clinical Trials
Heat Biologics Inc (NASDAQ:HTBX) management is pleased to complete the study in the pre-defined timeline. During the course of completed trial, there was no serious adverse event occurred related to the Vesigenurtacel-L vaccine. Moreover, Heat Biologics management said that the Phase 2 clinical trial can begin sooner than expected. The Phase 1/2 Vesigenurtacel-L clinical trial studies will have a different plan. It will cover a robust dose-response analysis. It will also accelerate the Phase 2 clinical trials of Vesigenurtacel-L.
The expectations
Jeff Wolf, the CEO of Heat Biologics Inc (NASDAQ:HTBX), said that the clinical team and investigators can now move ahead with Phase 2 enrollment process. Heat Biologics and its management are looking forward to the commencement of Phase 2 dosing. It will provide with the key data on its bladder cancer vaccine. If the studies are successful, then it can prove much beneficial for high-risk patients suffering from non-muscle invasive bladder cancer. It can provide the industry with a viable treatment option.
Enrollment and dosing
Heat Biologics Inc (NASDAQ:HTBX) expects the enrollment process of Vesigenurtacel-L Phase 2 study to be completed in 3Q2015. The management of Heat expects the top-line survival results to be released in the third quarter of 2016. The pre-defined observation period of trial is 12 months. As per the estimates released by the American Cancer Society, there will be more than 74,000 new bladder cancer diagnoses in 2014 alone. It indicates that there is a high demand for a viable treatment vaccine to treat bladder cancer in the industry.
