Purdue-developed 'fluorescent markers' begin Phase 3 clinical trials

Purdue-developed 'fluorescent markers' begin Phase 3 clinical trials

On Target Laboratories Inc., a privately held biotechnology company developing the use of Purdue University-discovered fluorescent markers to target and illuminate cancer during surgery, has announced the results of a multi-institutional Phase 2 clinical trial in which outcomes were improved for 26% of patients undergoing pulmonary resection for non-small-cell lung cancer (NSCLC). The results of the treatment, called OTL38, were presented at the 56 th annual Meeting of the Society of Thoracic Surgeons (STS), held last month in New Orleans, and were featured in a plenary session as a J. Maxwell Chamberlain Memorial Paper for General Thoracic Surgery, considered to be among the top-rated abstracts at STS. The treatment was developed in the Purdue laboratory of Philip Low in the Purdue Institute of Drug Discovery. Low is the Presidential Scholar for Drug Discovery and Ralph C. Corley Distinguished Professor of Chemistry-Biochemistry in the Department of Chemistry. Currently, there are 288 clinical trials performed or in process using Purdue-developed medical treatments at 4,841 sites across the globe. Our goal is to provide surgeons with new technology to help them provide a more complete resection to more patients. This gives patients the best chance of improved outcomes after surgery." Christopher Barys, president and CEO of On Target Laboratories 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. 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, 10 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%. Related Stories



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