Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA) to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®. The Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either breast cancer or melanoma. The FDA review included the efficacy and safety results of the NEO3-05 study and Neoprobe’s plans for the submission of a New Drug Application (NDA) for Lymphoseek. The NDA submission will be based on the clinical results of NEO3-05 and other already completed clinical evaluations of Lymphoseek. FDA encouraged Neoprobe to request a series of pre-NDA meetings in the coming months to review the components of the NDA prior to its formal submission. Neoprobe indicated to FDA that the Company plans to submit the NDA following satisfactory completion of these meetings.
“The performance of Lymphoseek in the Phase 3 study was excellent”
“We are very pleased with our recent discussions with the FDA review team regarding the NEO3-05 Phase 3 clinical results,” said David Bupp, Neoprobe’s President and CEO. “The results from this meeting have clearly confirmed our pathway for the submission of a NDA approximating our previously disclosed target timeline. The potential clearance of the NDA in 2011 would position Lymphoseek to be the first radiopharmaceutical for the preoperative or intraoperative identification of lymphatic tissue. Neoprobe will be working with FDA in the coming months to prepare for a successful review of the Lymphoseek NDA, and to determine additional information that could be provided on a post-marketing basis to extend or expand the labeling from that planned for the initial NDA.”
“The performance of Lymphoseek in the Phase 3 study was excellent,” said Dr. Fred Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “The primary and secondary efficacy endpoints of the study were met and no significant adverse events were reported that were directly attributed to Lymphoseek. The results of the Phase 3 trial have been favorably received by the members of the medical and scientific community. We plan to continue ongoing clinical evaluations of Lymphoseek that will be supportive of the NDA and subsequent amended claims for the product.”
The NEO3-05 Phase 3 study was an open label trial of node-negative subjects with either breast cancer or melanoma. It was designed to evaluate the safety and the accuracy of Lymphoseek while identifying the lymph nodes draining from the subject’s tumor site. To demonstrate the accuracy of Lymphoseek, each subject consenting to participate in the study was injected in proximity to the tumor with Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic mapping procedures. The primary efficacy objective of the study was to identify lymph nodes that contained the vital blue dye and to demonstrate a statistically acceptable concordance rate between the identification of lymph nodes with the vital blue dye and Lymphoseek. To be successful, the study needed to achieve a statistical p-value of at least 0.05.