Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that full results from the NEO3-05 study, demonstrating Lymphoseek® (99mTc-tilmanocept) met all primary and secondary endpoints in intraoperative lymphatic mapping (ILM) procedures. These results were featured yesterday at the Society for Nuclear Medicine (SNM) Annual Meeting in San Antonio. Recognition of these results by SNM follows closely the presentation and discussion at the American Society of Clinical Oncology (ASCO) Meeting in Chicago on June 6.
The primary endpoint of the NEO3-05 study was the comparison (the Concordance Rate, or the rate of agreement) of Lymphoseek versus vital blue dye (VBD). As is typical of regulatory comparator-based trials, which routinely compare a novel agent to an on-label agent approved in the indication being studied, Lymphoseek was tested against the only on-label agent approved in the U.S. for lymphatic mapping, vital blue dye. The FDA approved agents are used as the appropriate comparator for registration studies because they are supported by evidence from adequate and well controlled clinical trials to establish and demonstrate their expected performance. VBD meets this standard; no other compound currently does. Accordingly, and in consultation with the FDA, the Lymphoseek registration studies were designed to compare Lymphoseek performance to the required, on-label, approved agent, vital blue dye, in order to position Lymphoseek for FDA approval.
"The NEO3-05 data presented here at SNM reinforce findings of other clinical studies that suggest Lymphoseek provides significantly higher specificity and sensitivity, and a lower failed detection rate, than vital blue dye," said Dr. Vernon Sondak of the H. Lee Moffitt Cancer Center in Tampa, Florida.
Following the presentation of the Lymphoseek study data at the Society of Nuclear Medicine meeting, Dr. Robert Carretta, past president of the SNM and former Vice President, Medical Affairs at Mallickrodt Medical, the imaging pharmaceuticals division of Covidien, commented, "Having dealt with the FDA approval process for radiopharmaceuticals in a number of roles, including physician, clinical trial investigator, professional society leader and head of a commercial imaging agent development organization, I am well aware of FDA requirements for pivotal comparative studies. It is clear that only products specifically approved for the indication under investigation may be included as the appropriate comparator for purposes of registration with the FDA."
Also following the presentation, George Mills, M.D., former Director, Division of Medical Imaging and Radiopharmaceutical Drug Products at FDA and a Neoprobe consultant, also commented, "The design of both of Neoprobe's Phase 3 clinical trials for Lymphoseek, NEO3-05 and NEO3-09, have met the safety and efficacy expectations as planned with FDA. Neoprobe has conducted the trials in accordance with the parameters discussed and agreed with FDA. Direct comparison of Lymphoseek to vital blue dye - the only FDA-approved product for ILM procedures - is the appropriate comparator to demonstrate the clinical value of Lymphoseek."
NEO3-05 Primary Endpoint Met
The primary endpoint of the NEO3-05 study was the comparison (the Concordance Rate, or the rate of agreement) of Lymphoseek versus vital blue dye, where vital blue dye is considered by FDA as the only approved, on-label agent for lymphatic mapping, thus making it the appropriate requisite "Truth Standard" comparator for registration purposes. The Concordance Rate was analyzed on both a per-node and per-patient basis.
In NEO3-05, study subjects yielded a total of 215 lymph nodes stained with vital blue dye. Of these blue-stained nodes, Lymphoseek detected 210, for a Concordance Rate of 97.67%, which was a highly statistically significant finding (p<0.0001).
On a per-patient basis, the NEO3-05 study yielded a total of 136 patients with lymph nodes stained with vital blue dye. Of these patients, Lymphoseek detected the same blue-stained nodes in all 131 patients, for a Concordance Rate of 96.32%, a highly statistically significant finding (p<0.0001).
"The results presented yesterday reinforce prior clinical evidence indicating that Lymphoseek is an encouraging modality for surgical oncologists to intraoperatively identify and diagnose potentially cancerous lymph nodes in neoplastic disease versus the only currently approved agent, vital blue dye," said Dr. Fred Cope, Neoprobe's Senior Vice President, Pharmaceutical Research and Clinical Development.
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