Cooper team members from the Early Intervention Program (EIP) and Division of Infectious Diseases (ID) enrolled their first patient, and second in the nation, for a ground-breaking investigational HIV clinical trial. Cooper is one of only three sites participating in this study to evaluate EBT-101, a CRISPR-based gene therapy designed to remove HIV proviral DNA from affected cells as a functional cure for HIV.
Excision BioTherapeutics, a biotechnology firm, is sponsoring the Phase 1/2 clinical trial. This is the first time in medical history that researchers have attempted to excise, or eliminate, a viral infection from a patient’s infected cells using gene editing to potentially cure a patient.
HIV is a global disease with more than 1.2 million HIV-infected persons living in the United States. There currently is no cure for HIV. While patients with HIV have been able to keep the disease in remission with medication, the toxicity of current medications and need for life-long treatment presents a challenge for many patients.
The initial sample size of this ground-breaking study is nine participants. The first patient was enrolled at Washington University School of Medicine in St. Louis. Cooper enrolled the second patient in early November.
John D. Baxter, MD, Head of Infectious Diseases at Cooper, and interim Medical Director of the Cooper Research Institute, is the Principal Investigator for the study at Cooper.
“Cooper has been involved with research and medical care of persons with HIV-infection for decades” says Pamela Gorman, Administrative Director of EIP and ID, who has managed the center since 1999.
“We are very excited to be an EBT-101 clinical trial research site and provide the opportunity for our Cooper patients and persons across the country to participate in cutting edge HIV research,” says Dr. Baxter.
Enrolling the first patient and administering the dose of EBT-101 took an enormous effort, including team members from pharmacy, clinical decision unit, research, infectious diseases, nursing, medical informatics, and many more to make this milestone a reality.
“This milestone is a huge deal, not only for Cooper, but for the entire field of HIV treatment,” says Stephen Trzeciak, MD, MPH, Chief of Medicine at Cooper. “I offer congratulations and deep gratitude for the entire team that made this possible.”
Congratulations to this exceptional team for this enormous achievement. For more information about HIV research at Cooper please contact Yolanda Smith, Research Coordinator.