PolyPid to Host Virtual KOL Event on June 17, 2024, and Provide an Update on the Company’s Ongoing D-PLEX₁₀₀ Phase 3 Trial
- Charles E. Edmiston, Ph.D., Emeritus Professor of Surgery, Medical College of Wisconsin, to discuss the significant unmet medical need in surgical site infections prevention
- Company to Provide an Update on SHIELD II Phase 3 Study Enrollment During Event
PETACH TIKVA, Israel, June 10, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a virtual Key Opinion Leader (KOL) event on Monday, June 17, 2024, at 10:00 AM ET, to discuss the significant unmet medical need in surgical site infections and provide an update on the Company’s ongoing D-PLEX100 Phase 3 trial. To register, .
The event will feature Charles E. Edmiston, Ph.D. (Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), who will discuss the significant clinical and economic burden, and current medical practice, for the prevention of surgical site infections (SSIs). It will also highlight PolyPid's lead product candidate, D-PLEX100, and its ongoing Phase 3 SHIELD II trial evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. PolyPid management intends to provide an update on patient enrollment in SHIELD II during the event.
A live question and answer session with Professor Edmiston and the Company’s management team will follow the formal presentation.
About Charles E. Edmiston, Ph.D.
Charles E. Edmiston, Ph.D., is Emeritus Professor of Surgery, at the Medical College of Wisconsin in Milwaukee, Wisconsin, where he also served as Director and Professor, Surgical Microbiology and Hospital Epidemiology Research Laboratory, and Hospital Epidemiologist, Froedtert Hospital. Dr. Edmiston served as Adjunct Professor, Vanderbilt University School of Medicine, Nashville, Tennessee, and SSI Expert Liaison for the State of Wisconsin Division of Public Health. He completed his doctorate at Vanderbilt University in Nashville, Tennessee, joining the Surgical faculty in Milwaukee in 1984 to develop a surgical infectious disease research program.
Professor Edmiston is a fellow of the Infectious Disease Society of American, Association of Practitioners in Infection control and Epidemiology, Surgical Infection Society and Society for Healthcare Epidemiology of America. He is board credentialed in both Infection Control (CBIC) and as a Specialist in Clinical Microbiology (ASCP) and has served as a consultant to the U.S. Food and Drug Administration (FDA) as an expert on the infection control implications of implantable biomedical devices, including as Chairman of the General Hospital and Personal Use Device Panel of the Medical Devices Committee of the FDA. Dr. Edmiston has also served as Surgical Infection Society (SIS) liaison to the Hospital Infection Control Practice Advisory Committee (HICPAC) of the Centers for Disease Control and Prevention (CDC).
Dr. Edmiston is a current member of two Editorial Boards: Infection Control and Hospital Epidemiology, and Surgical Infections, and a past board member of Surgery, American Journal of Infection Control and JAMA Surgery. His major research interests include intravascular device-related infections, nosocomial risks in the operating room environment, biomedical-device associated infections, impact of selected risk factors for SSIs, perioperative antibiotic prophylaxis, surface disinfection, innovative strategies for reducing the risk of SSIs, molecular epidemiology of SSIs and perioperative antisepsis. Dr. Edmiston is the author of over 400 published peer-reviewed publications including book chapters, editorials reviews, manuals and abstracts, and has delivered over 500 national and international invited lectures/workshops.
About SHIELD II
SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.
About D-PLEX100
D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
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Contacts:
PolyPid Ltd.
Ori Warshavsky
COO – US
908-858-5995
Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
