HEALTHPOINT has enrolled the first of a planned 235 subjects into a Phase-II dose response study, investigating an experimental, cell-based wound therapy, HP802-247. It is intended for the treatment of venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts.
The first patient was enrolled at The Center for Clinical Research near San Francisco, led by the site’s principal investigator, Alexander Reyzelman, DPM. The study is being conducted by 28 investigators in 18 states.
The trial is the second of two planned-dose response trials, extending the dose range being tested and exploring two plausible dose frequencies. Enrollment into the trial is preceded by screening and run-in phases, and is expected to continue through the middle of 2010. The first trial showed promising results over a four-fold range of cell concentrations, administered weekly.
Bert Slade, Chief Medical Officer, HEALTHPOINT and co-author of the trial protocol, said: The start of enrollment into this multi-center, randomized trial is an important milestone for HEALTHPOINT. This is the largest cell therapy dose ranging trial ever undertaken in the area of wound healing.