Successful completion of a phase I clinical study for improving local control in patients with advanced colorectal cancer undergoing surgery
ROCKY HILL, Conn., Jan. 27, 2025 /PRNewswire-PRWeb/ -- ("Lumeda"), a biophotonics systems company formed to advance photodynamic therapy (PDT) for treating cancer, today announced the completion of a phase 1 clinical by Roswell Park Comprehensive Cancer Center of Buffalo, New York ("Roswell Park") using the company's DigiLumâ„¢ PDT system. Based on a device innovation demonstrated by Roswell Park, DigiLumâ„¢ represents a potentially revolutionary new way of administering PDT intraoperatively that is simplified, faster, and highly precise over legacy methods for improved, repeatable and reliable PDT results.
The study, designed and led by experts at Roswell Park, is titled "Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients with Locoregionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery – Phase I/II." This clinical trial evaluates the safety and potential benefits of 5-aminolevulinic acid (5-ALA) mediated fluorescence-guided surgical resection followed by intraoperative PDT as a novel method to improve the surgical outcomes of patients with advanced colorectal cancer. "This approach could prove to be an effective way to treat many cancers, and holds great promise because of the limited risks and side effects associated with photodynamic therapy, or PDT," said Dr. Anthony Dakwar, Medical Director of Perioperative Services, Department of Medical Oncology at Roswell Park and Principal Investigator of the study. "We have the potential to significantly reduce the incidence of recurrence with minimal side effects in patients undergoing surgery for colon and rectal cancers."
Results to date indicate that intraoperative PDT is well tolerated, with the phase 1 study achieving its primary safety endpoint. The study will now advance into the second phase that will further test the accuracy of image-guided fluorescence to detect residual disease and determine the potential efficacy of intraoperative PDT after image-guided fluorescence surgery. Phase 2 of the study is expected to commence by second quarter of 2025.
PDT represents a highly promising option for adjuvant therapy administered intraoperatively with no systemic toxicities and minimal side effects. PDT was developed at Roswell Park, which remains a worldwide leader in PDT research and clinical application as a treatment for many types of cancer. The collaboration between Roswell Park and Lumeda is accelerating the advancement of PDT from research to commercialization to expand its clinical utilization.
Acknowledgement:
Support of the clinical study was made in part under a grant from The University at Buffalo Clinical and Translational Science Institute via the NIH Clinical and Translational Science Award number PS-DAKWAR under UL1TR001412, and Lumeda Inc.
About Roswell Park Comprehensive Cancer Center:
From the world's first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer's grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit , call 1-800-ROSWELL (1-800-767-9355) or email [email protected].
About Lumeda:
Lumeda is a medical technology company advancing PDT for treating cancer with a preliminary focus on pleural malignancies and advanced colorectal tumors. The company applies advanced photonics and proprietary artificial intelligence (AI) software to automate and digitize PDT light delivery to improve physician control, reduce procedure time and enable data capture for treatment planning. The multidisciplinary Lumeda team has decades of experience in the photonics industry, with expertise in systems engineering and commercialization of new technology. Lumeda is committed to pioneering the advancement and utility of PDT for improved patient outcomes. For more information, please visit .
Media Contact
Paul E. Sanders, Lumeda, +1 860 614-0849, [email protected],
SOURCE Lumeda
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