RESEARCH TRIANGLE PARK, N.C. --(BUSINESS WIRE)--Humacyte, an innovator in biotechnology and regenerative medicine, announced today the initiation of a U.S. Phase II arterial bypass clinical trial of HUMACYL®, its investigational human acellular vessel (HAV), to test the safety and efficacy as a lower extremity arterial bypass vessel in patients with peripheral arterial disease (PAD). In this non-randomized trial with a target to enroll 20 patients over the next 12 months, HUMACYL will be surgically implanted in the above-the-knee, femoral-to-popliteal arterial position in the legs of patients who suffer from PAD to improve blood circulation. This study goal is to assess whether the vessel performs in the arterial bypass position, and is usable and suitable for repairing human arterial blood vessels.
The initiation of the Phase II trial in the United States is a continuation of previous arterial trial surgeries that were begun across multiple sites in Poland in 2013, and completed in 2015. Humacyte enrolled its first U.S. patient in the trial for arterial bypass at Brigham and Women’s Hospital in Boston, Massachusetts, under an FDA approved protocol. Patients will be enrolled in at least three other sites in the United States, including the UCSF Medical Center in San Francisco, California, Michigan Vascular Center in Flint, Michigan, and Duke University Hospital in Durham, North Carolina.
“The continuation of HUMACYL’s Phase II clinical studies as a conduit for blood flow in a patient with Peripheral Arterial Disease marks a major milestone in the field of regenerative medicine,” said Jeffrey H. Lawson, M.D., Ph.D., Chief Medical Officer of Humacyte. “We are heartened by the fact that Humacyte is expanding its footprint by leveraging our first in class, bioengineered vessel for multiple vascular surgery applications - including patients that undergo hemodialysis and patients with peripheral vascular disease.”
In addition to the arterial bypass study, Humacyte’s HAV is also currently undergoing a Phase III clinical trial for vascular access in patients with End Stage Renal Disease (ESRD) requiring renal replacement therapy and who are not candidates for fistula. The company is also planning the development of future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.
“Over 8.5 million people in the United States suffer from Peripheral Arterial Disease,” said Michael Belkin, M.D., Chief, Division of Vascular and Endovascular Surgery at Brigham and Women's Hospital. “If the results of this clinical trial are positive, then this solution has the potential to serve as a new clinical option for the many patients that face the need for artery bypass surgery each year. We are pleased to be the first medical facility in the United States that is taking part in a key study that may lead to a meaningful impact on patients’ cardiovascular health.”
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.
All statements, other than statements of historical fact, included in this announcement are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “will”, “anticipate”, “expect”, “believe”, “intend” and “should” or the negative of these terms or other comparable terminology. These statements relate to future events or Humacyte’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Humacyte’s actual results, performance or achievements to be materially different. Except as required by law, Humacyte assumes no obligation to update these forward-looking statements.