Neoprobe Corporation (NYSE: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced 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. The multi-center open label study was conducted in subjects with either breast cancer or melanoma in accordance with the clinical protocol registered on www.clinicaltrials.gov (NCT01106040).
"Neoprobe is pleased to announce the completion of this milestone and its significance in helping us advance toward fulfilling the regulatory requirements for a potential Lymphoseek approval by FDA," said David Bupp, Neoprobe's President and CEO. "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. We will hold a conference call at that time to discuss the clinical study results and the presentation of the results are planned at scientific conferences later in the second quarter."
An earlier Phase 3 multi-center study (NEO3-05) of Lymphoseek was 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 FDA as the primary efficacy objective for the NEO3-09 Phase 3 clinical study. No incidents related to drug safety have been reported in the Lymphoseek studies.
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