OncoNano Medicine has secured fast track designation from the US Food and Drug Administration (FDA) for ONM-100, an intraoperative imaging agent to identify tumors and metastatic lymph nodes that often go undetected during surgery.
Image: FDA accepts application from OncoNano for ONM-100. Photo: Courtesy of somkku9/FreeDigitalPhotos.net.
ONM-100 is the first product from a platform based upon the OncoNano’s library of micelles that respond to pH variability.
OncoNano Medicine regulatory affairs vice president Kathy Rath said: “These two positive responses from the FDA reflect the progress that we have made on ONM-100. The Fast Track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time.”
The company claims that ONM-100 when delivered to the tumor, fluoresces in the acidic tumor microenvironment, allowing surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras.
This platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. Presently, the company is concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.
OncoNano Medicine clinical development vice president Yalia Jayalakshmi said: “We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day.
“With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a Phase 2 clinical study in 2019.”
Last month, the company announced that it completed the Phase 1a clinical trial and expansion into Phase 1b for ONM-100 evaluation. The trial was conducted at the Tracer Center of Expertise, University Medical Center Groningen (UMCG) in Groningen, the Netherlands.
The Phase 1b portion of the study, will include an expansion phase at the highest does test in Phase 1a. Patients are being enrolled for this study.
In addition to testing for breast cancer and head and neck squamous cell carcinoma (HNSCC) which were studied in Phase 1a, Phase 1b will include patients with colorectal and esophageal cancers.