Navidea Biopharmaceuticals Inc (NYSEMKT:NAVB) shares jumped in Wednesday’s pre-market session, as the biopharmaceutical company released the results of analyses between Tuesday night and Wednesday morning with encouraging results for its Lymphoseek injection that is indicated to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.
NAVB was up 6.2% at $1.90 in recent pre-market trading, in a 52-week range of $1.11 to $3.31.
In its late-Tuesday release, the company said results from combined analyses of Phase 3 clinical trials that evaluated Lymphoseek efficacy in lymphatic mapping for identifying pathology-positive lymph nodes across multiple solid tumor types indicated Lymphoseek sensitivity for sentinel lymph node mapping was consistent across the tumor-type studies, regardless of whether surgery was conducted on the same day as, or on the day after injection of Lymphoseek.
“These results clearly demonstrate the clinical adaptability and utility of Lymphoseek in sentinel lymph node lymphatic mapping to reliably identify tumor-draining lymph nodes that may be at high risk of harboring cancer in patients with breast cancer, melanoma or head and neck squamous cell carcinoma,” said Cornelia Reininger, chief medical officer of Navidea.
In its Wednesday release, the company also said results from a post-hoc analysis of patient data from its Phase 3 clinical trial of Lymphoseek in head and neck cancer showed Lymphoseek localization to lymph nodes “showed a strong correlation with a full regional lymph node dissection and pathology analysis with a low false negative rate, a priority in identifying sentinel nodes.” In addition, it said, Lymphoseek was observed “to home preferentially to pathology-positive nodes at a higher rate than pathology-negative nodes.”
“These results suggest that Lymphoseek not only effectively targets sentinel lymph nodes, but further that its ability to highlight tumor-positive lymph nodes may be augmented mechanistically by the recruitment of macrophages to cancer-harboring lymph nodes,” the company added.
Navidea Biopharmaceuticals Inc (NYSEMKT:NAVB) Climbs on Encouraging Results
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