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 and skin from a human deceased donor, today’s current clinical standard of care, in a side-by-side comparison.
No adverse events or safety issues have been observed or reported to date, following careful evaluation of all patient data by the trial’s independent Safety Review Committee. Visible signs of efficacy were also promising; in all patients, Xeno-Skin™ and the human skin comparator were indistinguishable at the time of autografting.
“The field of burn care requires a multidisciplinary approach to treat the most complex injuries, and we are constantly seeking new options to improve patient recovery time,” said Jeremy Goverman, MD. “This trial demonstrates a novel way to treat complicated burns, and we are encouraged by the results thus far; additionally, this trial represents a step forward for the field of xenotransplantation.”
Especially notable, post-operative RT-PCR evaluation of all patient samples showed no evidence of detection of the porcine endogenous retrovirus. Historically, this concern has posed a significant hurdle to the widespread clinical use of porcine…
Go to the news source: From Pig to Patient: XenoTherapeutics Completes First Cohort of Patients in Firs…