CYTALUX Real-World Experience Presented at the American Association for Thoracic Surgery 104th Annual Meeting

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Apr 28, 2024, 16:30 ET

WEST LAFAYETTE, Ind., April 28, 2024 /PRNewswire/ -- Nicholas Baker, M.D., Director of Robotic Thoracic Surgery at the University of Pittsburgh Medical Center (UPMC) Passavant, presented key findings from independent research at the 104^th Annual Meeting of the American Association for Thoracic Surgery (AATS) in Toronto, Canada.

This is the first analysis of real-world experience for intraoperative molecular imaging (IMI) with CYTALUX following the phase 3 ELUCIDATE trial for cancer in the lung. The retrospective review included 39 sublobar resection procedures at UPMC that used CYTALUX to enhance the detection of cancer in the lung during surgery.

"The real-world clinical outcome mirrors the experience reported by the investigators in the phase 3 trial and reinforces that this approach improves our ability to detect primary and metastatic pulmonary lesions," said Dr. Baker.

The clinical outcome demonstrated an improvement in lung nodule localization, occult lesion identification and resection margin assessment, with CYTALUX aiding in the detection of primary lung cancer and metastatic lesions. The technology enabled the identification of 85.7% of primary lung cancer lesions compared to 67.9% identified using standard localization techniques without IMI. In addition, CYTALUX proved instrumental in identifying occult lesions intraoperatively that otherwise had no prior imaging correlates, revealing at least one additional malignancy in 18% of cases.

"This technology represents a significant advancement over the way we have traditionally managed lung cancer in the operating room," said Ryan Levy, M.D., Chief of Thoracic Surgery at UPMC and co-author of the analysis shared at AATS. "The clinically proven ability to specifically target and visually detect occult and difficult-to-find lung lesions has dramatic implications for the way we approach and manage patients with lung cancer. I anticipate some of the biggest impact will be in patients with multifocal ground glass type cancers."

CYTALUX was first approved as an adjunct for intraoperative identification of malignant lesions for use in adult patients with ovarian cancer in November 2021 and for adult patients with lung cancer in December 2022. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian and lung cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in certain cancers^1,2 and illuminates intraoperatively under near-infrared light.

For more information about CYTALUX, visit CYTALUX.com.

About On Target Laboratories, Inc.

On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX, the company's first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information visit www.ontargetlabs.com and www.cytalux.com.

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¹ Predina JD, Newton AD, Connolly C, Dunbar A, Baldassari M, Deshpande C, Cantu E 3rd, Stadanlick J, Kularatne SA, Low PS, Singhal S. Identification of a Folate Receptor-Targeted Near-Infrared Molecular Contrast Agent to Localize Pulmonary Adenocarcinomas. Mol Ther. 2018 Feb 7;26(2):390-403. doi: 10.1016/j.ymthe.2017.10.016. Epub 2017 Oct 26. PMID: 29241970; PMCID: PMC5835020.

² Kalli KR, Oberg AL, Keeney GL, et al. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecologic Oncology. 2008;108(3):619-626.

SOURCE On Target Laboratories, Inc.