Neoprobe, a developer of oncology surgical and diagnostic products, reported that a multi-center Phase 3 study of Lymphoseek has enrolled clinical subjects to achieve the minimum analysis goal of 196 lymph nodes, the study's primary accrual objective.
Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure referred to as Intraoperative Lymphatic Mapping (ILM).
The Phase 3 multi-center study, NEO3-05 of Lymphoseek was conducted in subjects with breast cancer or melanoma.
According to the study an overall localization rate of over 97% in lymph nodes was achieved in those patients where both a vital blue dye and Lymphoseek were used.
A similar concordance rate was established by Neoprobe and FDA as the primary efficacy objective for the NEO3-09 Phase 3 clinical study.
Neoprobe president and CEO David Bupp said Neoprobe is pleased for the completion of this milestone and its significance in helping them to advance toward fulfilling the regulatory requirements for a potential Lymphoseek approval by FDA.
"We are highly confident that the end points of the clinical study will be met and anticipate that full data will be available early in the second quarter following review by our clinical team," Bupp said.