Navidea Biopharmaceuticals said it has received a grant from the U.S. National Cancer Institute (NCI) to fund a clinical study of its Lymphoseek radiopharmaceutical agent in women with cervical cancer.
The fast-track Small Business Innovation Research (SBIR) grant provides up to $1.67 million in funding, which will be used to support a multicenter clinical study in patients with early cervical cancer. The study aims to assess and provide data in support of using Lymphoseek in sentinel lymph node biopsy procedures, according to Navidea.
The grant will be dispensed in two parts: The first six-month funding segment of nearly $166,000 will help Navidea identify and qualify trial sites and secure necessary contracts and institutional review board (IRB) approvals, according to the firm. Up to an additional $1.5 million provided in a second funding segment could be used to enroll participants and perform sentinel lymph node procedures and pathology evaluations, as well as perform data analyses on Lymphoseek's safety and effectiveness.
The study will compare Lymphoseek and an alternative lymphatic mapping agent, vital blue dye, for detecting sentinel lymph nodes in cervical cancer patients. It will also evaluate sentinel node pathology between agents and between the pathology of nonsentinel nodes, Navidea said.
Forty patients are expected to be enrolled in the study, which will last 1.5 years.
