Nov 7, 2020

From Pig to Patient: XenoTherapeutics Completes First Cohort of Patients in First US Clinical Trial of Live-Cell Xenotransplant; Evidence of Safety and Efficacy Allows for Accelerated Patient Enrollment From Pig to Patient: XenoTherapeutics Completes First Cohort of Patients in First US Clinical Trial of Live-Cell Xenotransplant; Evidence of Safety and Efficacy Allows for Accelerated Patient Enrollment Share Last updated Nov 5, 2020 BOSTON, MA, Nov. 05, 2020 (GLOBE NEWSWIRE) — XenoTherapeutics, a clinical-stage cell and gene therapy company engineering immune-compatible cells, tissues, and organs, has completed the first of two patient cohorts in the company’s Phase I clinical trial of Xeno-Skin™, a first-in-human, live-cell xenotransplant for the treatment of severe and extensive burn wounds. As a result, the U.S. Food and Drug Administration (FDA) has agreed to permit accelerated patient enrollment; patients may now enroll in the trial’s second cohort simultaneously. This first-in-human trial, conducted in partnership with the Massachusetts General Hospital, is expected to be completed by the end of 2020. More information is available at clinicaltrials.gov . “As an engineer and scientist, I’m trained to be skeptical and rely heavily on real data, and to prioritize facts above what we hope to see as a company. In this case, the evidence speaks for itself – there’s no doubt this works. Combine these results with our understanding of essential regulatory requirements specifically related to xenotransplantation, and our demonstrated capability in clinical grade manufacturing of xenotransplantation products, this seemingly small step has significant positive implications for patient care, for our field, and where we’re headed,” said XenoTherapeutics Corporation CEO Paul Holzer. “This affirms my enthusiasm for where our discoveries will go from here – very big things are coming soon.” Surgeries to implant Xeno-Skin™ were performed under the care of Dr. Jeremy Goverman (Principal Investigator) and Dr. John Schulz at the Massachusetts General Hospital (MGH) Sumner Redstone Burn Center. All patients who participated in the trial received surgical transplants of both live skin from a clinical-grade, genetically engineered porcine donor …