Neoprobe, a biomedical company, has announced that a multicenter Phase III study of Lymphoseek has reached the accrual of 203 lymph nodes, the study’s primary accrual objective.
The multi-center open label study has been conducted in patients with either breast cancer or melanoma. Based upon the intraoperative worksheets and preliminary pathology reports, the primary efficacy end-point of NEO3-05 has been achieved and no incidents related to drug safety have been reported in the Lymphoseek studies, said Neoprobe.
In the Phase II multi-center study of Lymphoseek, which was conducted in patients with breast cancer or melanoma, an overall localization rate of 94% in lymph nodes was achieved in those patients where both a patent blue dye and Lymphoseek were used, the company added.
A Phase III multi-center clinical trial for Lymphoseek in patients with breast cancer or melanoma is concluding and a protocol for a second Phase III clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck squamous cell carcinoma has been submitted to the FDA and the European Medicines Agency.
David Bupp, president and CEO of Neoprobe, said: Upon completion of a full analysis of the Phase III data, we will provide a complete update on the study results after all clinical data has been reviewed by our internal clinical team and external consultants. We expect full data will be available in the second quarter of 2009.