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.

Source: Neoprobe Corporation