May 13, 2016
Phase II Investigational Data Shows Potential for Patency and Safety in Patients with End-Stage Renal Disease
RESEARCH TRIANGLE PARK, N.C. – May 13, 2016 – Humacyte, an innovator in biotechnology and regenerative medicine, announced today that medical journal, The Lancet, published results from the company’s initial Phase II investigational studies to evaluate the safety and efficacy of HUMACYL®, the company’s investigational off-the-shelf bioengineered human acellular vessel (HAV) for use in patients with End-Stage Renal Disease (ESRD) who require hemodialysis.
Jeffrey H. Lawson, M.D., Ph.D., Humacyte’s Chief Medical Officer and Professor of Surgery and Pathology at Duke University Medical Center, and Laura Niklason, M.D., Ph.D., founder of Humacyte, Nicholas Greene Professor of Anesthesiology and Professor of Biomedical Engineering at Yale University, are the lead authors of the report.
The results are the most comprehensive assessment of any bioengineered vascular tissue to date. The Phase II clinical studies of the HAV were conducted at six hospitals across the United States (3) and Poland (3).
“The results of Humacyte’s Phase II clinical studies provide further evidence that this human acellular vessel could have significant impact on patients who are undergoing dialysis, and who require long-term, viable vascular access,” said Dr. Lawson. “The results mark a major milestone in vascular therapy and in the field of regenerative medicine, and we are very encouraged.”
The Lancet, a weekly peer-reviewed medical journal, is one of the world’s longest-standing and most prestigious medical publications. The link to the full article can be found here.
Humacyte’s HUMACYL was developed to address the shortcomings of the current standard of care for patients with ESRD where vascular options and their potential impact on good medical outcomes may diminish over time. Synthetic materials such as expanded polytetrafluoroethylene (ePTFE) grafts are routinely used for patients with ESRD who are not candidates for a new or replacement fistula. However, ePTFE grafts can become occluded over time, become infected, and may require multiple interventions or hospitalizations to keep them working. Other biological alternatives to ePTFE have been studied for dialysis access; however, none have shown long-term viability or gained wide acceptance.
Humacyte’s investigational HUMACYL vessels are formed in a proprietary bioreactor from banked human vascular smooth muscle cells and then are decellularized to remove cells and DNA. The vessels retain extracellular matrix proteins, like collagen, which are the same in all humans and which preserve the mechanical properties of the vessel. No cells from the recipient patient are required for the production process, and the vessels can be stored under refrigerated conditions and ready in the operating room at the time of need.
Highlights of the Phase II results:
- Overall, data from Phase II clinical studies of Humacyte’s HUMACYL suggests the vessel may have the potential for long-term functional vascular patency, or the ability of blood vessels to remain open and functional over time.
- In the study, HUMACYL vessels were cannulated and used safely for hemodialysis in the clinic and patients safely underwent interventions to maintain patency.
- HAVs had adequate blood flow rates for hemodialysis.
- No evidence of immune reaction to the HAV was seen in any patients.
- In this 60-patient Phase II trial, only one infection was attributed to HUMACYL.
- The implanted HAVs showed no clinical nor ultrasound evidence of structural degeneration over an average follow-up of 16 months in 60 patients, with the longest patient follow-up now more than 3 years.
- Following implantation, histological evidence demonstrated repopulation of HUMACYL with host cells, suggesting an ongoing process of host remodeling of the implanted acellular tissue.
Humacyte is now commencing a Phase III clinical study of the HAV. This study will be conducted at approximately 35 sites in the U.S., Europe and Israel with 350 evaluable subjects and will be the largest study of its kind to date. The company is also planning the potential development of future pipeline products which may improve treatment outcomes for patients with a variety of vascular and non-vascular diseases, such as Vascular Trauma, Coronary Artery Bypass, Replacement Trachea and Esophagus and bypass for Peripheral Arterial Disease.
Additional Authors: Marc H. Glickman M.D. FACS, Marek Ilzecki M.D. Ph.D., Tomasz Jakimowicz M.D. Ph.D., Andrzej Jaroszynski M.D. Ph.D., Eric K. Peden M.D., Alison J Pilgrim BM DPhil, Heather L. Prichard Ph.D., Guziewicz Malgorzata M.D. Ph.D., Stanisław Przywara M.D. Ph.D., Jacek Szmidt M.D. Ph.D., Jakub Turek M.D., Wojciech Witkiewicz M.D. Ph.D., Norbert Zapotoczny M.D., Tomasz Zubilewicz M.D. Ph.D.
Humacyte, Inc., a privately held company founded in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.
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