Neoprobe gets FDA approval for Lymphoseek clinical study

By Elaine Rigoli

Tampa, Fla., May 11 - Neoprobe Corp. has been granted authorization by the Food and Drug Administration to start patient enrollment in a phase 2 multi-center clinical study to evaluate the safety and efficacy of Lymphoseek for use in biopsy procedures for the detection of lymph nodes in patients with breast cancer or melanoma.

The authorization to commence enrollment follows the FDA's review of Neoprobe's responses to FDA-requested information in response to prior submissions by the company regarding the chemistry, manufacturing and control and non-clinical testing of Lymphoseek, according to a news release.

Neoprobe said it intends to enroll up to 80 patients at five of the leading cancer treatment centers in the United States under the amended phase 2 clinical protocol.

Neoprobe is a surgical and diagnostic product-development company headquartered in Dublin, Ohio.

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