SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. presented data from a Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, at the Society of Surgical Oncology (SSO) 2023 International Congress on Surgical Cancer Care, occurring March 22-25 in Boston, MA. Data from the study revealed that the primary endpoint was achieved in 50% of the evaluable patients undergoing peritoneal carcinomatosis surgery.
The primary objective of this Phase 2 study was to determine if the administration of pegsitacianine (1 mg/kg) prior to surgery results in the detection of additional disease following standard of care surgical resection of peritoneal metastases. The results reveal that, under pegsitacianine guidance, 20 of 40 evaluable patients (50%) had pathology-confirmed disease resected after fluorescent visualization that was not resected in the planned standard of care surgery. In this trial, pegsitacianine was well tolerated; the only notable pegsitacianine-related adverse event was a transient, self-resolving, non-anaphylactic infusion-related reaction experienced by approximately 25% of patients.
“These results show that pegsitacianine can safely be administered up to three days in advance of surgery, without any impact on the planned surgical approach. Importantly, the results of this Phase 2 trial demonstrate pegsitacianine’s potential as a new advance for real-time surgical imaging for peritoneal metastasis surgery,” said Kartik Krishnan MD, PhD, Chief Medical Officer of OncoNano Medicine. “I look forward to working alongside the U.S. Food and Drug Administration (FDA) to plan for further development and explore the most efficient opportunities to bring pegsitacianine to patients.”
The results come at the heels of the Company’s January 2023 announcement that pegsitacianine received Breakthrough Therapy Designation by the U.S. FDA as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARDTM platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.