The Purdue University-discovered fluorescent markers that target and illuminate cancer during surgery have done well in a multi-institutional Phase II clinical trial in which outcomes were improved for 26% of patients undergoing pulmonary resection for non-small-cell lung cancer (NSCLC). The “Boilermakers” technology is being commercialized by On Target Laboratories, a privately held biotech company in West Lafayette, Indiana, at the Purdue campus.

Lung Cancer Procedures

Lung cancer is the leading cause of cancer-related deaths in the United States. Pulmonary resection, either a wedge resection, segmentectomy, or lobectomy, is recommended for most patients who have operable stage I-II non-small cell lung cancer. Intraoperative molecular imaging (IMI), also referred to as fluorescence-guided surgery, may increase the likelihood of a more complete surgical resection, which could translate into increased survival for patients and reduced re-operations or adjuvant treatment for hospitals.

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ fluorescent markers are composed of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue. On Target’s first novel compound, OTL38 targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via IV infusion one to 24 hours before surgery, allowing the surgeon to identify malignant tissue during the procedure using the near-infrared camera.

The Treatment: OTL38

Called OTL38, it is currently under development in two Phase III clinical trials for both lung and ovarian cancer indications. The trials are being conducted under a special protocol agreement with the U.S. Food and Drug Administration. The Purdue-born technology also received fast-track designation for both the lung and ovarian cancer indications and an orphan designation for ovarian cancer from the FDA.

According to one top expert in the field, Dr. Inderpal (Netu) S. Sarkaria of the Department of Cardiothoracic Surgery at the University of Pittsburgh Medical Center, “OTL38 is the first technique that is specific to imaging adenocarcinomas of the lung, which is one of the most common types of invasive lung cancer.” He continued “Near-infrared imaging with OTL38 may be a powerful tool to help surgeons significantly improve the quality of lung cancer by more clearly identifying tumors and allowing the surgeon to see better and completely remove them—one of the most vital components in the overall care of patients with the disease.” This treatment was developed in the lab of Philip Low in the Purdue Institute of Drug Discovery.

Purdue Shines a Light on Progress

Recently reported, OTL38 is just one of many Purdue innovations—there are 288 clinical trials performed or in the process using Purdue-developed medical treatments at 4,841 sites across the globe.

The Study

Conducted over 18 months, the study included 92 patients eligible for analysis. There were no drug-related serious adverse events, and 24 patients, or 26%, were impacted during pulmonary resection, with 8% of patients having a change in their stage due to the use of IMI.

The study showed that IMI improved localization of small and peripheral lesions, which can be difficult for surgeons to identify visually or through manual palpitation, and enabled localization of otherwise unlocalizable lesions in 11 patients, or 12%. Further, ten additional cancers were found in seven patients, or 8%. During the Specimen Check Phase, when the surgeon confirms that the nodule is in the specimen and analyzes the margins, surgeons thought all margins were adequate, yet back-table inspection using IMI revealed inadequate margins in eight patients or 9%.

On Target Laboratories & Disclosures

On Target Laboratories, a privately held biotech company in West Lafayette, Indiana, at the Purdue campus, was founded by Philip Low (of Purdue) in 2010. They have raised over $60 million in investment. Founder Low, of course, also works at the university. The technology is licensed through the Purdue Research Foundation Office of Technology of Commercialization. The Purdue Institute of Drug Discovery is situated near Discovery Park District, a $1 billion-plus long -term enterprise to support a transformational center of innovation on the western edge of the Purdue University campus.

Lead Research/Investigator

Philip Low, the Presidential Scholar for Drug Discovery and Ralph C. Corley Distinguished Professor of Chemistry-Biochemistry in the Department of Chemistry.

Source: Eurekalert

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