Neoprobe announced that its multicenter Phase 3 study of Lymphoseek, a tracing agent, has reached its accrual goal to achieve the minimum analysis goal of 196 lymph nodes. This study is being conducted in patients with either breast cancer or melanoma. An earlier Phase 3 multicenter study (NEO3-05) of Lymphoseek was also conducted in subjects with breast cancer or melanoma. In the NEO3-05 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 the FDA as the primary efficacy objective for the NEO3-09 Phase 3 clinical study.
Lymphoseek is a radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping (ILM).
For more information call (614) 793-7500 or visit www.neoprobe.com.