Navidea Biopharmaceuticals Inc said its cancer diagnostic agent was effective in identifying the first lymph node reached by the disease in patients with head and neck cancer, paving the way to expand its use in all solid cancers.
The company said a safety monitoring committee recommended that the trial be stopped early due to the positive results.
The diagnostic agent, Lymphoseek, correctly identified cancer in 38 of the 39 patients determined to have cancer in their lymph nodes, the company said, citing an interim analysis of a late-stage trial of the imaging agent that is already approved for use in two other cancers.
The company said detection of cancer-affected nodes by Lymphoseek led to the removal of only about four lymph nodes per patient on an average, while surgery — considered the gold standard to detect the spread of cancer — led to the removal of about 38 lymph nodes per patient.
The false negative rate of the study was 2.56 percent, which was also statistically significant, Navidea said.
The company expects to file an approval application for the expanded use of Lymphoseek later in the year.
Lymphoseek was approved in March - the first such drug to be approved in 30 years - to identify cancer-carrying lymph nodes in patients with breast cancer or melanoma.
The agent will be launched in the second quarter by drug wholesaler Cardinal Health, Navidea's commercial partner.
The company also intends to get it approved for mapping sentinel lymph nodes, the first nodes affected by cancer and which indicate whether the cancer has spread to other parts of the body. There is no approved agent for this indication.
Navidea is also developing two other imaging agents to detect Alzheimer's disease and Parkinson's disease.
The company's shares, which have fallen 26 percent since Lypmhoseek's approval, closed at $2.55 on the American Stock Exchange on Wednesday.
(Reporting by Esha Dey and Vrinda Manocha in Bangalore; Editing by Maju Samuel)