Biostage selects Iqvia to manage FDA-approved clinical trial

Biostage (BSTG) announced that it had selected IQVIA (IQV) as the contract research organization to manage its first clinical trial. The FDA-approved clinical trial is an open-label trial assessing both safety and efficacy in up to ten patients requiring the removal of up to 6cm of their esophagus for any reason at up to five hospitals in the U.S. The primary endpoint is the establishment of a continuous biological conduit at three months following implantation. David Green, Biostage’s founder, Chair of the Board and interim Chief Executive Officer commented, "We are very pleased to be partnering with IQVIA to perform the clinical trials needed to bring our Biostage Esophageal Implant product candidate to the patients who need it. According to the American Cancer Society, current treatment options for patients diagnosed with esophageal cancer result in only 20% survival at five years and according to the World Health Organization’s International Agency for Research on Cancer, every year more than 600,000 patients worldwide are diagnosed with esophageal cancer."